Overview

Effects on Ovarian Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292003)(COMPLETED)(P05723)

Status:
Completed
Trial end date:
2008-01-01
Target enrollment:
0
Participant gender:
Female
Summary
The primary purpose of this study is to evaluate the effects of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) on ovarian function.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Drospirenone
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Megestrol
Polyestradiol phosphate
Criteria
Inclusion Criteria:

- Willing to use COC for at least 6 cycles.

- 18 - 35 years of age at screening.

- Body Mass Index (BMI) of >/= 17 and
- Good physical and mental health.

- Willing to use condoms as the sole contraceptive method during screening cycle and 1
post-treatment cycle.

- Willing to give informed consent.

Exclusion Criteria:

- Contraindications for contraceptive steroids (general).

- Additional contraindications (renal, hepatic or adrenal insufficiency).

- Breastfeeding.

- Present use (or use within 2 months prior to start of the trial medication) of the
following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine,
topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole,
sex

steroids (other than pre- and post treatment contraceptive method) and herbal remedies
containing Hypericum perforatum (St. John's Wort).

- Administration of any other investigational drugs and/or participation in another
clinical trial within 2 months prior to the start of the trial medication or during
the trial period.

- Abnormal cervical smear at screening, or documentation of an abnormal smear performed
within 6 months before screening.

- Clinically relevant abnormal laboratory result at screening as judged by the
investigator.