A randomized, open-label, comparative trial to evaluate the effects on ovarian function 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 µg ethinyl estradiol (EE).
Phase 3
Completed
- Conditions
- contraceptieContraception
- Registration Number
- NL-OMON29993
- Lead Sponsor
- Organon Nederland BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
Inclusion Criteria
Healthy women and willing to use a combined contraceptive for 6 cycles.
Age at least 18-35 years.
Exclusion Criteria
Contraindications for contraceptive steroids
Additional contraindications related to the antimineralocorticoid activity of drospirenone
Breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Ovarian function (incidence of ovulation, maximum follicular diameter, serum<br /><br>progesterone, estradiol, FSH and LH concentrations)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Cervical mucus receptivity (Insler score), endometrial thickness, contraceptive<br /><br>efficacy, vaginal bleeding patterns, androgen, SHBG and folic acid<br /><br>concentrations</p><br>