| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01709318 | A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012) | PHASE2 | COMPLETED | 666 | — | — | Dec 12, 2012 | Oct 22, 2013 | May 28, 2024 | - | — |
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...