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

Organon

Status and phase

Completed

Phase 3

Conditions

Contraception

Treatments

Drug: NOMAC-E2

Drug: DRSP-EE

Study type

Interventional

Funder types

Industry

Identifiers

NCT00511433

P05723

Organon protocol 292003

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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 </= 35.
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.