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Also known as Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR)
Nomegestrol contraceptive vaginal ring · 1 trial · 1 indication
The Mean Menstrual Cramping Pain score was calculated as the average of the three highest daily menstrual cramping scores (item #3 of the Menstrual Distress Questionnaire: "Cramps") in the baseline cycle and treatment Cycle 2, respectively. The daily menstrual cramping pain score was based on five pain categories: none (0); mild (1); moderate (2); strong (3); and severe (4). In case of absence of withdrawal bleeding, or onset of menstruation, the mean of the three highest menstrual cramping pain scores recorded within Days 21-28 was used for analysis. The Mean Menstrual Cramping Pain Score in the baseline or subsequent cycles could range from 0 (none) to 4 (severe).
| Arm | Type | Description |
|---|---|---|
| NOMAC-E2 700/300 mcg | EXPERIMENTAL | NOMAC-E2 700/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| NOMAC-E2 900/300 mcg | EXPERIMENTAL | NOMAC-E2 900/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| ENG-E2 100/300 mcg | EXPERIMENTAL | ENG-E2 100/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| ENG-E2 125/300 mcg | EXPERIMENTAL | ENG-E2 125/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| Placebo | PLACEBO_COMPARATOR | Placebo will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| Name | Type | Description |
|---|---|---|
| Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR) | DRUG | Either 700 or 900 mcg NOMAC and 300 mcg E2 intravaginal ring for two 28-day cycles |
| Etonogestrel containing contraceptive vaginal ring (ENG-CVR) | DRUG | Either 100 or 125 mcg ENG and 300 mcg E2, intravaginally for two 28-day cycles |
| Placebo | DRUG | Placebo to match vaginal ring, intravaginally for two 28-day cycles |
| Ibuprofen | DRUG | Ibuprofen 400 mg will be dispensed throughout the entire study as needed as rescue medication for treating menstrual cramping pain. The maximum daily ibuprofen dose is 3200 mg (8 tablets) |
Inclusion Criteria: * Body mass index (BMI) ≥18 and ≤35 * Established diagnosis of primary dysmenorrhea * If of child-bearing potential must agree to use condoms for contraception during the entire screening period, treatment period, and post-treatment period until the final study visit, unless she...