A randomized, open-label, comparative, multi-center trial to evaluate contraceptive efficacy, cycle control, safety and acceptability of a monophasic combined oral contraceptive (COC) containing 2.5 mg nomegestrol acetate (NOMAC) and 1.5 mg estradiol (E2), compared to a monophasic COC containing 3 mg drospirenone (DRSP) and 30 ug ethinyl estradiol (EE).
Phase 3
Completed
- Conditions
- contraceptieContraception
- Registration Number
- NL-OMON29882
- Lead Sponsor
- Organon Nederland bv
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 102
Inclusion Criteria
Healthy Sexually active women at risk for pregnancy and not planning to use condoms
Women in need for contraception and willing to use an Oral Contraceptive
Age at least 18 - 50 years
Exclusion Criteria
Contraindications for contraceptive steroids
Additional contraindications related to the antimineralocorticoid activity of drospirenone
Abnormal cervical smear at screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>-To assess contraceptive efficacy, vaginal bleeding patterns( cycle control),<br /><br>general safety and acceptability of the NOMAC-E2 COC in a large group of women<br /><br>aged 18-50 years</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To evaluate the effects of the NOMAC-E2 COC on satisfaction and health<br /><br>related quality of life, libido, acne, menstrual symptoms and body weight;<br /><br>- To explore the aforementioned characteristics of the NOMAC-E2 COC in<br /><br>comparison with the DRSP-EE COC.</p><br>