Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nomegestrol · 1 trial · 1 indication
Ovulation was defined as having 2 or more consecutive progesterone concentrations \>16 nmol/L within 5 days, confirmed by ultrasound evidence of ovulation (follicular rupture or preceding presence of a follicle-like structure \>15 mm in size).
Maximum progesterone (Max P) was defined as the maximum progesterone value. Ovulation was defined as 2 or more consecutive progesterone concentrations \>16 nmol/L within 5 days during the 3 treatment cycles, supported by ultrasound evidence of ovulation. The Max P values greater than 16 nmol/L are presented by vaginal ring group and cycle.
Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day.
| Arm | Type | Description |
|---|---|---|
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/day | EXPERIMENTAL | Participants will receive nomegestrol acetate 17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/day | EXPERIMENTAL | Participants will receive nomegestrol acetate 17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/day | EXPERIMENTAL | Participants will receive nomegestrol acetate 17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/day | EXPERIMENTAL | Participants will receive etonogestrel 17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/day | EXPERIMENTAL | Participants will receive etonogestrel 17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/day | EXPERIMENTAL | Participants will receive etonogestrel 17β-estradiol (ENG-E2)125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| NuvaRing® | ACTIVE_COMPARATOR | Participants will receive NuvaRing® (etonogestrel-ethinyl estradiol \[ENG-EE\] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| Name | Type | Description |
|---|---|---|
| Nomegestrol acetate (NOMAC) | DRUG | Daily release of 500, 700, or 900 μg. |
| Etonogestrel (ENG) | DRUG | Daily release of 75, 100, 120 or 125 μg |
| Ethinyl estradiol (EE) | DRUG | Daily release of 15 μg |
| Estradiol (E2) | DRUG | Daily release of 300 μg |
Inclusion Criteria: * Body mass index (BMI) ≥18 and ≤35 * Regular cycles from 24 to 35 days in length, with an intra-individual variation of ±3 days permitted within this range * Good physical and mental health Exclusion Criteria: * Diabetes mellitus with vascular involvement * Presence of a seve...
Nomegestrol is an investigational small molecule being studied for use in healthy volunteers and for contraception. It is being developed by Organon & Co. (NYSE: OGN) and is currently in Phase 2 clinical development for contraception.
Nomegestrol is being developed by Organon & Co., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol OGN. The drug is currently in Phase 2 clinical development for contraception.
Nomegestrol is in Phase 2 clinical development for contraception. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials for the drug are ongoing or completed, with one Phase 2 trial completed.
Nomegestrol has been studied in clinical trials including NCT00711607, a Phase 1 pharmacokinetic study in healthy volunteers, and NCT01709318, a Phase 2 dose-finding study for contraception. Both trials have been completed.
Nomegestrol is related to Nomegestrol acetate, a progestin used in hormonal contraception. Clinical trials for Nomegestrol have evaluated Nomegestrol acetate in combination with estradiol for contraceptive purposes.