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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8175A-022 | Other Identifier | Merck Protocol Number | |
| SCH 900121 P06448 | Other Identifier | Merck Protocol ID |
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Business reasons
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The purpose of this study was to assess the contraceptive efficacy of a nomegestrol acetate + 17ß-estradiol (NOMAC-E2) combined oral contraceptive (COC) in healthy, sexually-active American women at risk for pregnancy. Vaginal bleeding patterns of women taking NOMAC-E2 were assessed and compared to those of women taking a norethisterone acetate + ethinyl estradiol (NETA-EE) COC. The safety of NOMAC-E2 was also assessed.
Participants were randomized to receive either NOMAC-E2 or NETA-EE in a 3:1 ratio. As of Amendment 1 (which increased the sample size of the NOMAC-E2 group), the randomization ratio was adapted accordingly for participants randomized after the sample size increase.
This study was terminated early. The decision to terminate the study was based upon difficulties encountered with data collection (related to incomplete e-Diary entries) in concert with business considerations. The decision was not related to any new or unexpected safety or efficacy findings with NOMAC-E2. As a result of this early termination, none of the pre-specified efficacy endpoints were analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOMAC-E2 | Experimental | Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28. |
|
| NETA-EE | Active Comparator | Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOMAC-E2 | Drug | NOMAC-E2 film-coated oral tablets containing 2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of In-Treatment Pregnancies Per 100 Woman Years of Exposure (Pearl Index) | Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure. | Up to 1 year (13 cycles) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Participants kept e-diaries to record their vaginal bleeding events. They were asked to record, on a daily basis, whether they experienced vaginal bleeding, which included BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. (This is also known as "breakthough" bleeding.) Vaginal bleeding that required >=1 pad/tampon per day was classified as BLEEDING. Vaginal bleeding that did not require a pad/tampon per day was classified as SPOTTING. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31069056 | Derived | Rolla E. Endometriosis: advances and controversies in classification, pathogenesis, diagnosis, and treatment. F1000Res. 2019 Apr 23;8:F1000 Faculty Rev-529. doi: 10.12688/f1000research.14817.1. eCollection 2019. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NOMAC-E2 | Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28. |
| FG001 | NETA-EE | Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | NOMAC-E2 | Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28. |
| BG001 | NETA-EE |
| 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 | Number of In-Treatment Pregnancies Per 100 Woman Years of Exposure (Pearl Index) | Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure. | Planned analysis for this primary endpoint was not performed due to early study termination. | Posted | Up to 1 year (13 cycles) |
|
Up to 54 weeks
All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication. One treated participant in the NOMAC-E2 treatment group had incomplete data and was not included in the Safety Analyses.
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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 | NOMAC-E2 | Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Internal hernia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D004997 | Ethinyl Estradiol |
| C031621 | ferrous fumarate |
| ID | Term |
|---|---|
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
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| NETA-EE | Drug | NETA-EE film-coated oral tablets containing 1 mg norethisterone acetate and 10 μg ethinylestradiol. |
|
|
| Placebo | Other | tablet |
|
| ethinylestradiol (EE) | Drug | EE 10 μg tablet |
|
| ferrous fumarate | Drug | ferrous fumarate 75 mg tablet |
|
| Up to 1 year (13 cycles) |
| Percentage of Participants With an Absence of Withdrawal Bleeding | Participants kept e-diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether vaginal bleeding was present. Absence of withdrawal bleeding was defined as no bleeding/spotting during the expected bleeding period. | Up to 1 year (13 cycles) |
| Percentage of Participants Who Experienced At Least One Adverse Event | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. | Up to 54 weeks |
| Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event | Up to 54 weeks |
| Change From Baseline in Body Weight | Participants' body weights were measured in a consistent manner throughout the trial, using standardized equirpment. Last In-Treatment Measurement refers to a participant's end of trial visit, the timing of which differed among participants. | Baseline and Week 52 |
| Lost to Follow-up |
|
| Site discontinued study participation |
|
| Screen failure |
|
| Protocol Violation |
|
| Pregnancy wish |
|
| Pregnancy |
|
| Physician Decision |
|
| Non-compliance with study drug |
|
| Study terminated by sponsor |
|
| Participant discontinued; drug related |
|
| Part. discontinued; unrelated to drug |
|
| Non-compliance with protocol |
|
| Participant moved |
|
| Participant withdrew consent |
|
| Withdrawal by Subject |
|
Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| NETA-EE |
Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28. |
|
| Secondary | Percentage of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Participants kept e-diaries to record their vaginal bleeding events. They were asked to record, on a daily basis, whether they experienced vaginal bleeding, which included BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. (This is also known as "breakthough" bleeding.) Vaginal bleeding that required >=1 pad/tampon per day was classified as BLEEDING. Vaginal bleeding that did not require a pad/tampon per day was classified as SPOTTING. | Planned analysis for this secondary endpoint was not performed due to early study termination. | Posted | Up to 1 year (13 cycles) |
|
|
| Secondary | Percentage of Participants With an Absence of Withdrawal Bleeding | Participants kept e-diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether vaginal bleeding was present. Absence of withdrawal bleeding was defined as no bleeding/spotting during the expected bleeding period. | Planned analysis for this secondary endpoint was not performed due to early study termination. | Posted | Up to 1 year (13 cycles) |
|
|
| Secondary | Percentage of Participants Who Experienced At Least One Adverse Event | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. | All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication. One treated participant in the NOMAC-E2 treatment group had incomplete data and was not included in the Safety Analyses. | Posted | Number | Percentage of Participants | Up to 54 weeks |
|
|
|
| Secondary | Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event | All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication. One treated participant in the NOMAC-E2 treatment group had incomplete data and was not included in the Safety Analyses. | Posted | Number | Participants | Up to 54 weeks |
|
|
|
| Secondary | Change From Baseline in Body Weight | Participants' body weights were measured in a consistent manner throughout the trial, using standardized equirpment. Last In-Treatment Measurement refers to a participant's end of trial visit, the timing of which differed among participants. | Participants from All Subjects as Treated Population (all randomized participants who took at least one dose of trial medication) who had data available for Change from Baseline in Body Weight endpoint. | Posted | Mean | Standard Error | kilograms | Baseline and Week 52 |
|
|
|
| 20 |
| 2,465 |
| 0 |
| 2,465 |
| EG001 | NETA-EE | Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28. | 8 | 604 | 0 | 604 |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Bacterial pyelonephritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Breast cellulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Pelvic inflammatory disease | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Tubo-ovarian abscess | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Traumatic haemothorax | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Traumatic liver injury | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
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| Epiphysiolysis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Ovarian fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Abortion spontaneous complete | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Substance abuse | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
The investigator agrees to provide to the Sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including slides and texts of oral or other public presentations that report any results of the trial). The Sponsor has the right to review and comment on publications, abstracts, slides, and manuscripts, as well as the data analysis and presentation.
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| After Cycle 9 (n=1468; n=391) |
|
| After Cycle 13 (n=462; n=145) |
|
| Last In-Treatment Measurement (n=2231; n=549) |
|