Phase 2
N=666
A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012)
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT01709318 ↗Enrolled (actual)
666
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Percentage of Participants With Ovulation Incidence, by Cycle — 0; 0; 0; 0 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nomegestrol acetate (NOMAC) (Drug); Etonogestrel (ENG) (Drug); Ethinyl estradiol (EE) (Drug); Estradiol (E2) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Organon and Co
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Ovulation Incidence, by Cycle |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Progesterone Concentrations >16 Nmol/L, by Cycle |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Breakthrough Bleeding and/or Spotting During Cycle 3 |
14.6; 13.3; 17.5; 13.6; 16.3; 6.4 | — |
| SECONDARY Percentage of Participants With Absence of Withdrawal Bleeding and/or Spotting During Cycle 2 |
5.5; 1.9; 4.4; 7.8; 3.7; 1.9 | — |
| SECONDARY Intensity of Withdrawal Bleeding During Cycle 2 |
0.87; 0.92; 0.86; 0.90; 0.92; 0.93 | 0.096 |
| SECONDARY Intensity of Breakthrough Bleeding and/or Spotting During Cycle 3 |
0.42; 0.80; 0.68; 0.73; 0.67; 0.33 | 1.000 |
| SECONDARY Percentage of Participants Who Experienced At Least One Adverse Event |
43.0; 40.0; 43.6; 37.7; 39.0; 46.5 | — |
| SECONDARY Percentage of Participants Who Experienced At Least One Serious Adverse Event |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants Who Experienced At Least One Drug-Related Adverse Event |
26.6; 23.5; 26.9; 29.9; 26.0; 31.4 | — |
| SECONDARY Percentage of Participants With Any Drug-Related Serious Adverse Event |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event |
3.8; 4.7; 2.6; 2.6; 0; 1.2 | — |
Summary
The primary objective of this trial was to identify at least one next generation ring (NGR) that demonstrates inhibition of ovulation (which was considered confirmed if in the subset of participants ovulation was observed in less than 15% of the participants at any time during the 3 treatment cycles of the study) and cycle control that was non-inferior to NuvaRing®, as judged by the incidence of breakthrough bleeding and/or spotting (BTB-S) during Cycle 3. The primary hypothesis was that at least 1 of the 6 NGRs would show inhibition of ovulation and cycle control during Treatment Cycle 3 that is non-inferior to NuvaRing®, as judged by the incidence of BTB-S.
Eligibility Criteria
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 severe or multiple risk factor(s) for venous or arterial thrombosis
- Severe dyslipoproteinemia
- Severe hypertension
- Presence or history of pancreatitis associated with severe hypertriglyceridaemia
- Presence or history of severe hepatic disease
- Undiagnosed vaginal bleeding
- Known or suspected pregnancy
- Participation in another investigational drug study within 30 days prior to screening visit
- History of malignancy ≤5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
- Documented abnormal cervical smear result in 6 months prior to screening visit
- Sterilization using a fallopian tube occlusion device (e.g., Essure method)
- Sex hormone therapy within 2 months prior to screening visit for purpose other than contraception, or injectable hormonal contraception within 6 months prior to screening
Data sourced from ClinicalTrials.gov (NCT01709318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.