NCT05264506

Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive

A Phase 3, Open-label, Multi-center, Single-arm Study to Assess Contraceptive Efficacy and Safety of the Nomegestrol Acetate + 17β-estradiol Combined Oral Contraceptive (OG-8175A) in Premenopausal Females Aged 14 to 35 Years (Inclusive)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,055 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 14 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is evaluating Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive in Premenopausal Females Aged 14 to 35 Years (Inclusive).

Detailed description

This is a Phase 3, Open-label, Multi-center, Single-arm Study to Assess Contraceptive Efficacy and Safety of the Nomegestrol Acetate + 17β-estradiol Combined Oral Contraceptive (OG-8175A) in Premenopausal Females Aged 14 to 35 Years (Inclusive). Potential participants must be sexually active and engage in heterosexual vaginal intercourse at least once per month with a partner who is not known to be subfertile, sterilized, or infertile, and should not routinely use any other form of contraception. A total of 2,680 fertile premenopausal women aged 14 to 35 years (inclusive) will be screened to achieve about 1,878 (with at least 657 participants with BMI ≥30 kg/m2) being allocated to study treatment. Over 1,000 total participants are expected to complete 1 year of treatment (13 cycles). The total duration of study participation will be up to 60 weeks, which includes a Pre-treatment Period of approximately 6 weeks, a Treatment Period of 52 weeks, and a Follow-up Period of 2 weeks after the last intake of study drug.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	NOMAC-E2 COC	Dosage Formulation: Film-coated Tablet Unit Dose Strength: Nomegestrol acetate (NOMAC) 2.5 mg and estradiol (E2) 1.5 mg; Each blister strip contains 28 tablets: 24 tablets with the active drug (number 1 to 24) and 4 tablets with placebo (number 25 to 28). Dosing Instructions: oral. Take 1 tablet daily at about the same time as directed.

Timeline

• Start date: 2022-02-17
• Primary completion: 2024-01-12
• Completion: 2024-01-26
• First posted: 2022-03-03
• Last updated: 2025-11-21
• Results posted: 2025-11-21

Locations

103 sites across 1 country: United States

Regulatory

• FDA-regulated drug study