A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012)

NCT ID: NCT01709318

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 666 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-12
• Study Completion Date: 2013-10-22

Brief 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.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/day

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.

Group Type: EXPERIMENTAL

Nomegestrol acetate (NOMAC)

Intervention Type: DRUG

Daily release of 500, 700, or 900 μg.

Estradiol (E2)

Intervention Type: DRUG

Daily release of 300 μg

Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/day

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.

Group Type: EXPERIMENTAL

Nomegestrol acetate (NOMAC)

Intervention Type: DRUG

Daily release of 500, 700, or 900 μg.

Estradiol (E2)

Intervention Type: DRUG

Daily release of 300 μg

Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/day

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.

Group Type: EXPERIMENTAL

Nomegestrol acetate (NOMAC)

Intervention Type: DRUG

Daily release of 500, 700, or 900 μg.

Estradiol (E2)

Intervention Type: DRUG

Daily release of 300 μg

Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/day

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.

Group Type: EXPERIMENTAL

Etonogestrel (ENG)

Intervention Type: DRUG

Daily release of 75, 100, 120 or 125 μg

Estradiol (E2)

Intervention Type: DRUG

Daily release of 300 μg

Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/day

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.

Group Type: EXPERIMENTAL

Etonogestrel (ENG)

Intervention Type: DRUG

Daily release of 75, 100, 120 or 125 μg

Estradiol (E2)

Intervention Type: DRUG

Daily release of 300 μg

Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/day

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.

Group Type: EXPERIMENTAL

Etonogestrel (ENG)

Intervention Type: DRUG

Daily release of 75, 100, 120 or 125 μg

Estradiol (E2)

Intervention Type: DRUG

Daily release of 300 μg

NuvaRing®

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.

Group Type: ACTIVE_COMPARATOR

Etonogestrel (ENG)

Intervention Type: DRUG

Daily release of 75, 100, 120 or 125 μg

Ethinyl estradiol (EE)

Intervention Type: DRUG

Daily release of 15 μg

Interventions

Nomegestrol acetate (NOMAC)

Daily release of 500, 700, or 900 μg.

Intervention Type: DRUG

Etonogestrel (ENG)

Daily release of 75, 100, 120 or 125 μg

Intervention Type: DRUG

Ethinyl estradiol (EE)

Daily release of 15 μg

Intervention Type: DRUG

Estradiol (E2)

Daily release of 300 μg

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Duijkers I, Klipping C, Heger-Mahn D, Fayad GN, Frenkl TL, Cruz SM, Korver T. Phase II dose-finding study on ovulation inhibition and cycle control associated with the use of contraceptive vaginal rings containing 17beta-estradiol and the progestagens etonogestrel or nomegestrol acetate compared to NuvaRing. Eur J Contracept Reprod Health Care. 2018 Aug;23(4):245-254. doi: 10.1080/13625187.2018.1506101. Epub 2018 Sep 11.

Reference Type: RESULT

PMID: 30203681 (View on PubMed)

Other Identifiers

2012-002459-41

Identifier Type: OTHER

Identifier Source: secondary_id

P06109

Identifier Type: OTHER

Identifier Source: secondary_id

MK-8175A/MK-8342B-012

Identifier Type: OTHER

Identifier Source: secondary_id

P06109

Identifier Type: -

Identifier Source: org_study_id