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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8175A-017 | Other Identifier | Merck |
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This study will investigate the efficacy and safety of the monophasic
combined oral contraceptive (COC) containing 2.5 mg NOMAC and 1.5 mg E2 in
healthy fertile Indian women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOMAC-E2 2.5 mg/1.5 mg | Experimental | Participants will receive combined oral contraceptive NOMAC-E2 2.5 mg/1.5 mg tablet for 13 consecutive 28-day cycles. Each 28-day cycle with consist of 24 active tablets and 4 placebo tablets taken at approximately the same time each day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nomegestrol acetate (NOMAC) | Drug | Oral tablet with daily release of 2.5 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of In-treatment Pregnancies | Day 1 of Treatment Cycle 1 Through Day 28 of Treatment Cycle 13, plus up to 2 additional days (Study Days 1-366) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing an Adverse Event (AE) or Serious AE | "From Visit 1 up to 30 days after the last dose of study medication (up to Study Day 394). |
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Inclusion Criteria:
home address
Exclusion Criteria:
or cerebrovascular accident
thrombosis
hypertriglyceridemia
trial medication
- Investigational drug use or participation in another clinical trial within
2 months of signing Informed Consent Form for current trial
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| ID | Term |
|---|---|
| C038501 | nomegestrol acetate |
| D004958 | Estradiol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Estradiol (E2) |
| Drug |
Daily release of 1.5 mg |
|
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |