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Also known as Nomegestrol acetate (NOMAC), Nomegestrol
nomegestrol and estradiol · 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 and estradiol is being developed for contraception. It is a small molecule combination product studied in a Phase 2 dose-finding trial evaluating ovarian function and vaginal bleeding in a next-generation vaginal ring. The trial enrolled 666 healthy female volunteers aged 18 years and older.
Nomegestrol and estradiol targets the progesterone receptor (PGR) as an agonist. Nomegestrol acetate acts as a progestin agonist at PGR, while estradiol provides estrogenic activity. This combination supports contraceptive effects through hormonal regulation of the reproductive cycle.
Nomegestrol and estradiol is being developed by Organon & Co., which trades under the ticker OGN. Organon is the sponsor of the clinical program evaluating this combination for contraception.
Nomegestrol and estradiol is in Phase 2 development. The completed Phase 2 trial was a dose-finding study assessing ovarian function and vaginal bleeding. It is an investigational product and has not been approved by the FDA for the studied indication.
Nomegestrol and estradiol has been studied in one completed Phase 2 trial, NCT01709318, titled A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings. The trial was randomized, double-blind, active-controlled, and enrolled 666 healthy female volunteers.
Nomegestrol and estradiol is also known as nomegestrol acetate and estradiol, and the progestin component is often abbreviated as NOMAC or referred to as nomegestrol. These names refer to the same combination product containing nomegestrol acetate and estradiol.