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To assess the effects of AZD4901 when given in multiple doses to females with Polycystic Ovary Syndrome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD4901 20 mg once a day | Experimental | AZD4901 20 mg once a day |
|
| AZD4901 20mg twice a day | Experimental | AZD4901 20mg twice a day |
|
| AZD4901 40 mg twice a day | Experimental | AZD4901 40 mg twice a day |
|
| Placebo to match AZD4901 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD4901 (oral) | Drug | Patients randomized to 1 of 4 treatment groups: AZD4901 20 mg once a day, AZD4901 20 mg twice a day, AZD4901 40 mg twice a day or placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lutenising Hormone (LH) AUC(0-8) Ratio to Baseline at Day 7 | Change-from-baseline of luteinising hormone area under the concentration-time curve from time zero to 8 hours postdose [AUC(0-8)] at Day 7 | Day 7 |
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Inclusion Criteria:
Female patients between the ages of 18 to 45 years (inclusive). Suitable veins for cannulation or repeated venipuncture. Body mass index (BMI) between 18 and 40 kg/m2 (inclusive). A diagnosis of polycystic ovary disease. Amenorrhea or oligomenorrhea (defined as ≤ 6 menses per year). Negative serum pregnancy test at screening. Negative urine pregnancy test before randomisation. Not be breast-feeding. Not have been pregnant within the 6 months prior to screening.
Exclusion Criteria:
Perimenopausal or reached natural menopause, defined as FSH > 10 IU/L. Menstruated within the month prior to the baseline visit. Hysterectomy or bilateral oophorectomy or both. Clinically relevant disease and abnormalities (past or present), and in particular causes of abnormal vaginal bleeding.
Withdrawals from oral contraceptives if their LH levels are below 3 IU/L when retested within 7 ± 1 days of the baseline visit.
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| Name | Affiliation | Role |
|---|---|---|
| Jyothis George, MD | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Research Associates | Miami | Florida | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27459523 | Derived | George JT, Kakkar R, Marshall J, Scott ML, Finkelman RD, Ho TW, Veldhuis J, Skorupskaite K, Anderson RA, McIntosh S, Webber L. Neurokinin B Receptor Antagonism in Women With Polycystic Ovary Syndrome: A Randomized, Placebo-Controlled Trial. J Clin Endocrinol Metab. 2016 Nov;101(11):4313-4321. doi: 10.1210/jc.2016-1202. Epub 2016 Jul 26. |
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67 patients were recruited to the study, of which 65 received doses of AZD4901 between 20 mg qd and 40 mg bid or placebo. Two patients were excluded due to poor venous access
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Two matching placebo tablets for both the morning and evening doses |
| FG001 | 20 mg AZD4901 Once Daily | One 20-mg AZD4901 tablet and 1 placebo tablet for the morning dose and 2 placebo tablets for the evening dose |
| FG002 | 20 mg AZD4901 Twice Daily | One 20-mg AZD4901 tablet and 1 placebo tablet for both the morning and evening doses |
| FG003 | 40 mg AZD4901 Twice Daily | Two 20-mg AZD4901 tablets for both the morning and evening doses |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Two matching placebo tablets for both the morning and evening doses |
| BG001 | 20 mg AZD4901 Once Daily | One 20-mg AZD4901 tablet and 1 placebo tablet for the morning dose and 2 placebo tablets for the evening dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Lutenising Hormone (LH) AUC(0-8) Ratio to Baseline at Day 7 | Change-from-baseline of luteinising hormone area under the concentration-time curve from time zero to 8 hours postdose [AUC(0-8)] at Day 7 | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 7 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 20 mg AZD4901 Once Daily | One 20-mg AZD4901 tablet and 1 placebo tablet for the morning dose and 2 placebo tablets for the evening dose |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martin L. Scott, MD/PhD | AstraZeneca Pharmaceuticals LP | 781-472-5130 | martin.scott@astrazeneca.com |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D004700 | Endocrine System Diseases |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| Placebo to match AZD4901 | Drug | Patients randomized to 1 of 4 treatment groups: AZD4901 20 mg once a day, AZD4901 20 mg twice a day, AZD4901 40 mg twice a day or placebo |
|
| Orlando |
| Florida |
| United States |
| Research Site | Springfield | Missouri | United States |
| Research Site | Berlin | Germany |
| Research Site | Belfast | United Kingdom |
| Research Site | Edinburgh | United Kingdom |
| Research Site | London | United Kingdom |
| Dose administration non-compliance |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Patient met exclusion criterion 16. |
|
| BG002 | 20 mg AZD4901 Twice Daily | One 20-mg AZD4901 tablet and 1 placebo tablet for both the morning and evening doses |
| BG003 | 40 mg AZD4901 Twice Daily | Two 20-mg AZD4901 tablets for both the morning and evening doses |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
20 mg AZD4901 twice daily administered orally
| OG003 | 40 mg AZD4901 Bid | 40 mg AZD4901 twice daily administered orally |
|
|
|
| 0 |
| 15 |
| 6 |
| 15 |
| EG001 | 20 mg AZD4901 Twice Daily | One 20-mg AZD4901 tablet and 1 placebo tablet for both the morning and evening doses | 1 | 17 | 13 | 17 |
| EG002 | 40 mg AZD4901 Twice Daily | Two 20-mg AZD4901 tablets for both the morning and evening doses | 0 | 17 | 5 | 17 |
| EG003 | Placebo | Two matching placebo tablets for both the morning and evening doses | 0 | 16 | 6 | 16 |
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nodule | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Vulvovaginal Mycotic Infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Gastrointestinal Infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Influenza Like Illness | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Hepatic Enzyme Increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Pelvic Pain | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vaginal Discharge | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hot Flush | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
|
AstraZeneca will manage the publication of the results of the Clinical Trial in partnership with the authors. AstraZeneca recognises that Institutions/Investigators may wish to make publications regarding Clinical Trial results. The Institution/Investigator agrees to collaborate in good faith with AstraZeneca. Prior to any such publication, the Institution/Investigator shall provide AstraZeneca with preliminary data and drafts of proposed publications.
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |