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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...
Nomegestrol contraceptive vaginal ring is an investigational small molecule contraceptive delivered as a vaginal ring. It is being developed by Organon & Co. (ticker OGN) and has been studied in a Phase 2 trial for primary dysmenorrhea, the pain associated with menstruation. It is also known as the nomegestrol acetate contraceptive vaginal ring, or NOMAC-CVR.
Nomegestrol contraceptive vaginal ring has been studied for dysmenorrhea, specifically primary dysmenorrhea, in a Phase 2 clinical trial. Primary dysmenorrhea refers to menstrual pain not caused by underlying pelvic disease. The drug is a contraceptive vaginal ring, and its development for dysmenorrhea remains investigational.
Nomegestrol contraceptive vaginal ring targets the progesterone receptor, or PGR, and acts as a progesterone receptor agonist. Nomegestrol acetate binds and activates this receptor, which is the basis for its progestogenic activity. The molecular target is recorded as PGR with an agonist target class.
Organon & Co., which trades under the ticker OGN, is developing the nomegestrol contraceptive vaginal ring. The company sponsored the Phase 2 study of the vaginal ring in primary dysmenorrhea. Organon is the developer associated with this asset.
Nomegestrol contraceptive vaginal ring is in Phase 2 development. It is investigational and has not been approved by the FDA. One Phase 2 trial has been completed, and no trials are currently active. The completed study was randomized, double-blind, and placebo-controlled, enrolling 439 female participants aged 18 years and older.
Nomegestrol contraceptive vaginal ring has been evaluated in one completed Phase 2 trial, NCT01670656, titled A Study to Evaluate the Effect of Contraceptive Vaginal Rings on Primary Dysmenorrhea (P08257/MK-8175A/MK-8342B-057). The trial enrolled 439 female participants aged 18 years and older, was randomized, double-blind, and placebo-controlled, and studied dysmenorrhea.
Yes. Nomegestrol contraceptive vaginal ring is also known as the nomegestrol acetate contraceptive vaginal ring, abbreviated NOMAC-CVR. NOMAC stands for nomegestrol acetate, the active small molecule. Both names refer to the same Organon & Co. investigational vaginal ring product.