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| Name | Class |
|---|---|
| Laboratorios Andromaco S.A. | INDUSTRY |
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Assess the efficacy of 2 Cervical Pessaries containing 6.3 g and 7.7 g micronized progesterone for the prevention of preterm delivery, established through spontaneous birth before gestation weeks 32 (31 weeks and 6 days) and 34 (33 weeks and 6 days), when the pessary is inserted during weeks 16th and 24th and removed at 36 weeks and 6 days in pregnant women at high risk of premature birth.
Participant selection will be performed by screening the general population of pregnant women with single fetus monitored by the Hospital Healthcare Network, to investigate by serial transvaginal ultrasound performed between gestation weeks 16 (0 day to 7 days) and 24 (0 day to 7 days) those patients who have a cervical length between 10 mm and 25 mm, and/or women with a single fetus and cervical length ≥10 mm presenting one or more of the following risk factors:
After insertion of the pessary or beginning of the administration with vaginal progesterone capsules and until 28 weeks of gestation, participants in the 3 treatment groups will be monitored every 4 weeks at the most or more often, if the site has established so as a control standard. After 28 weeks, patients should be monitored every 2 weeks.
The proportions of spontaneous preterm delivery before gestation weeks 32 and 34 will be compared between the control group and the 2 groups with the pessaries containing different doses of progesterone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progesterone Cervical Pessary 6.3 g | Experimental | 90 pregnant women with Progesterone Cervical Pessary |
|
| Progesterone Cervical Pessary 7.7 g | Experimental | 90 pregnant women with Progesterone Cervical Pessary |
|
| Progesterone 200 mg vaginal capsules | Active Comparator | 90 pregnant women using Progesterone 200 mg vaginal capsules daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progesterone Cervical Pessary 6.3 g | Drug | Progesterone Cervical Pessary low dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Not Giving Birth Before Week 32 and Week 34 of Gestation | To assess the efficacy of Cerclage Pessaries containing 6.3 g and 7.7 g micronized progesterone for the prevention of preterm delivery, established through spontaneous parturition before gestation weeks 32 (31 weeks and 6 days) and 34 (33 weeks and 6 days), when the pessary is inserted between weeks 16 and 24 and removed at 36 weeks and 6 days in pregnant women at high risk of premature delivery. For the purpose of this analysis, pregnancies were no longer considered as high risk for the event if delivery occurred at week 34 of gestation and beyond. Gestational age was determined by the last menstruation date and were confirmed by measurement of the craniocaudal length obtained in the first trimester ultrasound, or by measurement of the cephalic circumference in the second trimester ultrasound predominating the actual date of the last menstrual period. The number of participants not giving birth before 32 weeks and 34 weeks are reported. | Up to 36 weeks of gestational age |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Premature Rupture of Membranes | A participant with premature rupture of membrane typically recalls a sudden gush of fluid loss from the vagina, or steady loss of small amounts of fluid. Participants who reported vaginal discharge were examined by a physician. | Up to 36 weeks of gestational age |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancies with:
Cervical or vaginal injuries prior to insertion of the pessary (e.g., cervical erosion secondary to trauma, infection, or carcinoma; vesicovaginal or rectovaginal fistulas).
Unconscious, severely ill or mentally disabled patients, or under 16 years of age.
Patients for whom use of progesterone is contraindicated.
Patients with history of thrombosis.
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| Name | Affiliation | Role |
|---|---|---|
| Grünenthal Study Director | Grünenthal GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Chile, Hospital Barros Luco | Santiago | 7501257 | Chile | |||
| Complejo Asistencial Dr. Sótero del Río (CASR) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15901258 | Background | Dodd JM, Crowther CA, Cincotta R, Flenady V, Robinson JS. Progesterone supplementation for preventing preterm birth: a systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2005 Jun;84(6):526-33. doi: 10.1111/j.0001-6349.2005.00835.x. | |
| 19076950 | Background | Berghella V. Novel developments on cervical length screening and progesterone for preventing preterm birth. BJOG. 2009 Jan;116(2):182-7. doi: 10.1111/j.1471-0528.2008.02008.x. |
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The trial started on 02 Sep 2013 with the enrollment of the first participant and was completed on 13 Mar 2017 when the last participant completed the last follow-up examination according to the protocol. 271 participants signed and informed consent. All 271 were randomized and treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Progesterone Cervical Pessary (6.3 g) | Cervical Pessary (PCP) with sustained release of progesterone. The PCP is inserted by investigator to participant at risk of preterm birth and remains installed with no further intervention except at the time of removal. |
| FG001 | Progesterone Cervical Pessary (7.7 g) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 16, 2016 | Mar 1, 2018 |
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| Progesterone 200 mg vaginal capsules | Drug | Progesterone 200 mg vaginal capsules daily |
|
|
| Progesterone Cervical Pessary 7.7 g | Drug | Progesterone Cervical Pessary high dose |
|
| Anatomical Feature: Length of the Uterine Cervix |
During the pregnancy the length of the uterine cervix will be assessed. The rational is that premature birth is associated with uterine cervix shortening. The length of the cervix was determined using ultrasound examination. A positive change from baseline indicates a positive development, i.e. less likely to result in a preterm birth. The comparison between premature an normal birth initially planned by the protocol was not analyzed. |
| Up to 36 weeks of gestational age. Results are reported for all assessments from baseline through final visit, for a total of 8 visits, and for up to 36 weeks of gestational age. |
| Anatomical Feature: Position of the Uterine Cervix | During the pregnancy the position of the uterine cervix will be assessed. The rational being that premature birth is associated with uterine cervix positioning. The position of the cervix was determined using transvaginal ultrasound examination. In the change from baseline visit a positive value change indicated that the investigator believed that the position of the cervix changed in a positive manner to facilitate a term birth. The comparison between premature an normal birth initially planned by the protocol was not analyzed. The results reported are the degrees of the cervix position relative to the longitudinal axis of the uterus. | Up to 36 weeks of gestational age. Results are reported for all assessments from baseline through final visit, for a total of 8 visits, and for up to 36 weeks of gestational age. |
| Acceptability and Tolerance of Use of the Cerclage Pessary | A questionnaire was planned to be used to compare acceptability and tolerance in the insertion, during pregnancy and during the extraction of Cerclage Pessary. Data from this questionnaire was not collected. | Up to 36 weeks of gestational age |
| Number of Adverse Events Related With the Use of Treatment | The number of adverse events reported were analyzed as being related with the treatment as well as for unexpectedness. | Up to 36 weeks of gestational age |
| Santiago |
| Chile |
| Unidad de Alto Riesgo Obstétrico y Medicina Perinatal y en el Centro Perinatal Oriente (CERPO), Hospital Santiago Oriente, Dr. Luis Tisné Brousse | Santiago | Chile |
| Universidad de Chile, Hospital Clínico San Borja Arriarán | Santiago | Chile |
| 19351272 | Background | Jayasooriya GS, Lamont RF. The use of progesterone and other progestational agents to prevent spontaneous preterm labour and preterm birth. Expert Opin Pharmacother. 2009 Apr;10(6):1007-16. doi: 10.1517/14656560902851403. |
| 10885649 | Background | Newcomer J. Pessaries for the treatment of incompetent cervix and premature delivery. Obstet Gynecol Surv. 2000 Jul;55(7):443-8. doi: 10.1097/00006254-200007000-00023. |
| 12747228 | Background | Arabin B, Halbesma JR, Vork F, Hubener M, van Eyck J. Is treatment with vaginal pessaries an option in patients with a sonographically detected short cervix? J Perinat Med. 2003;31(2):122-33. doi: 10.1515/JPM.2003.017. |
| 22475493 | Background | Goya M, Pratcorona L, Merced C, Rodo C, Valle L, Romero A, Juan M, Rodriguez A, Munoz B, Santacruz B, Bello-Munoz JC, Llurba E, Higueras T, Cabero L, Carreras E; Pesario Cervical para Evitar Prematuridad (PECEP) Trial Group. Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial. Lancet. 2012 May 12;379(9828):1800-6. doi: 10.1016/S0140-6736(12)60030-0. Epub 2012 Apr 3. |
Cervical Pessary (PCP) with sustained release of progesterone. The PCP is inserted by investigator to participant at risk of preterm birth and remains installed with no further intervention except at the time of removal. |
| FG002 | Progesterone 200 mg Vaginal Capsules | Progesterone 200 mg vaginal capsules: Progesterone 200 mg vaginal capsules daily by participant. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat.
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| ID | Title | Description |
|---|---|---|
| BG000 | Progesterone Cervical Pessary (6.3 g) | Cervical pessary (PCP) with sustained release of progesterone. The PCP is inserted by investigator to participant (at risk of preterm birth) and remains installed with no further intervention except at the time of removal. |
| BG001 | Progesterone Cervical Pessary (7.7 g) | Cervical pessary (PCP) with sustained release of progesterone. The PCP is inserted by investigator to participant (at risk of preterm birth) and remains installed with no further intervention except at the time of removal. |
| BG002 | Progesterone 200 mg Vaginal Capsules | Progesterone 200 mg vaginal capsules: Progesterone 200 mg vaginal capsules daily by participant. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | meter |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kilogram |
| |||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter |
| |||||||||||||||
| Medical History - Prior Preterm Birth | Count of Participants | Participants |
| ||||||||||||||||
| Medical History - Prior Pregnancy Premature Rupture of Membrane | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Not Giving Birth Before Week 32 and Week 34 of Gestation | To assess the efficacy of Cerclage Pessaries containing 6.3 g and 7.7 g micronized progesterone for the prevention of preterm delivery, established through spontaneous parturition before gestation weeks 32 (31 weeks and 6 days) and 34 (33 weeks and 6 days), when the pessary is inserted between weeks 16 and 24 and removed at 36 weeks and 6 days in pregnant women at high risk of premature delivery. For the purpose of this analysis, pregnancies were no longer considered as high risk for the event if delivery occurred at week 34 of gestation and beyond. Gestational age was determined by the last menstruation date and were confirmed by measurement of the craniocaudal length obtained in the first trimester ultrasound, or by measurement of the cephalic circumference in the second trimester ultrasound predominating the actual date of the last menstrual period. The number of participants not giving birth before 32 weeks and 34 weeks are reported. | 271 participants comprised the Intention-to-treat analysis (ITT) population at baseline, 268 participants at gestation week 32, and 262 participants at gestation week 34. | Posted | Count of Participants | Participants | Up to 36 weeks of gestational age |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Premature Rupture of Membranes | A participant with premature rupture of membrane typically recalls a sudden gush of fluid loss from the vagina, or steady loss of small amounts of fluid. Participants who reported vaginal discharge were examined by a physician. | Intention-to-Treat Population | Posted | Count of Participants | Participants | Up to 36 weeks of gestational age |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Anatomical Feature: Length of the Uterine Cervix | During the pregnancy the length of the uterine cervix will be assessed. The rational is that premature birth is associated with uterine cervix shortening. The length of the cervix was determined using ultrasound examination. A positive change from baseline indicates a positive development, i.e. less likely to result in a preterm birth. The comparison between premature an normal birth initially planned by the protocol was not analyzed. | Intention-to-treat (ITT). | Posted | Mean | Standard Deviation | millimeter | Up to 36 weeks of gestational age. Results are reported for all assessments from baseline through final visit, for a total of 8 visits, and for up to 36 weeks of gestational age. |
| |||||||||||||||||||||||||||||||||
| Secondary | Anatomical Feature: Position of the Uterine Cervix | During the pregnancy the position of the uterine cervix will be assessed. The rational being that premature birth is associated with uterine cervix positioning. The position of the cervix was determined using transvaginal ultrasound examination. In the change from baseline visit a positive value change indicated that the investigator believed that the position of the cervix changed in a positive manner to facilitate a term birth. The comparison between premature an normal birth initially planned by the protocol was not analyzed. The results reported are the degrees of the cervix position relative to the longitudinal axis of the uterus. | Intention-to-treat (ITT). | Posted | Mean | Standard Deviation | degrees | Up to 36 weeks of gestational age. Results are reported for all assessments from baseline through final visit, for a total of 8 visits, and for up to 36 weeks of gestational age. |
| |||||||||||||||||||||||||||||||||
| Secondary | Acceptability and Tolerance of Use of the Cerclage Pessary | A questionnaire was planned to be used to compare acceptability and tolerance in the insertion, during pregnancy and during the extraction of Cerclage Pessary. Data from this questionnaire was not collected. | No participants were analyzed | Posted | Up to 36 weeks of gestational age |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Adverse Events Related With the Use of Treatment | The number of adverse events reported were analyzed as being related with the treatment as well as for unexpectedness. | Intention-to-treat (ITT) | Posted | Number | events | Up to 36 weeks of gestational age | number of adverse events | number of adverse events |
|
up to 36 weeks of gestational age (participants were in the trial for up to 20 weeks).
Treatment emergent adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Progesterone Cervical Pessary 6.3 g | 91 pregnant women with Progesterone Cervical Pessary Progesterone Cervical Pessary: Progesterone Cervical Pessary: 6.3 g Progesterone Cervical Pessary: 7.7 g | 0 | 91 | 36 | 91 | 77 | 91 |
| EG001 | Progesterone Cervical Pessary 7.7 g | 90 pregnant women with Progesterone Cervical Pessary Progesterone Cervical Pessary: Progesterone Cervical Pessary: 6.3 g Progesterone Cervical Pessary: 7.7 g | 0 | 90 | 35 | 90 | 73 | 90 |
| EG002 | Progesterone 200 mg Vaginal Capsules | 90 pregnant women using Progesterone 200 mg vaginal capsules daily Progesterone 200 mg vaginal capsules: Progesterone 200 mg vaginal capsules daily | 0 | 90 | 33 | 90 | 65 | 90 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast abscess | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Cervical incompetence | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Foetal growth restriction | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Oligohydramnios | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Preeclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Shortened cervix | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Threatened labour | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Asymptomatic bacteriuria | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Cerebral ventricle dilatation | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Haemorrhage in pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Polihidroamnios | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Ventricular hypoplasia | Congenital, familial and genetic disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Drug use disorder | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Diabetic Metabolic Decompensation | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Umbilical cord abnormality | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pelvic pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Premature labor | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Renal Colic | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Foetal hypokinesia | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Bacteriuria | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Foetal cerebrovascular disorder | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vaginal erosion | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Multiple congenital anomalies | Congenital, familial and genetic disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vaginal infection NOS | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| HELLP syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Coital bleeding | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cervix haemorrhage uterine | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Uterine contractions during pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Congenital uterine anomaly | Congenital, familial and genetic disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Duodenogastric reflux | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Cervicitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Gastrenteritis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Vaginitis gardnerella | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Vulvovaginal candidasis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Vulvovaginitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Gynaecological chlamydia infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Ureaplasma infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Mycoplasma infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Vaginitis chlamydial | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| Amniocentesis abnormal | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Ultrasound uterus | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Ultrasound uterus abnormal | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Ureaplasma test positive | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Mycoplasma test positive | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Foetal renal imaging abnormal | Investigations | MedDRA (17.0) | Systematic Assessment |
| |
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pubic pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vulvovaginal warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Gestational diabetes | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Haemorrhage in pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Polyhydramnios | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Threatened labour | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Uterine hypotonus | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Umbilical cord abnormaility | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Uterine contractions during pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Uterine contractions abnormal | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Foetal hypokinesia | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Uterine irritability | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pruritus genital | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vuvovaginal pruritus | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cervix haemorrhage uterine | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vulvovaginal discomfort | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Genital discharge | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vaginal erosion | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Cervix oedena | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Shortened cervix | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Vulvovaginal pain | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Skin striae | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Utricaria | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pruritus allergic | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Grünenthal GmbH | +49 241 569 3223 | clinical-trials@grunenthal.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 12, 2017 | Mar 1, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011374 | Progesterone |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| No birth before 34 weeks |
|
|
| Participants |
|
|
|
|
Progesterone 200 mg vaginal capsules: Progesterone 200 mg vaginal capsules daily by participant. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
| Units | Counts |
|---|
| Participants |
|
| number of adverse events |
|
|