Overview
Effects on Ovarian Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292003)(COMPLETED)(P05723)
Status:
Completed
Completed
Trial end date:
2008-01-01
2008-01-01
Target enrollment:
0
0
Participant gender:
Female
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 3Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
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 = 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.