Efficacy and Safety of the Combined Oral Contraceptive (COC) NOMAC-E2 Compared to a COC Containing DRSP/EE (292001)(COMPLETED)(P05724)

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged 18-50 years.

• 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:

• 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 (OC) for 12 months (13 cycles).

• At least 18 but not older than 50 years of age at the time of screening.

• Body mass index (BMI) of >/= 17 and
• Good physical and mental health.

• Willing to give informed consent in writing.

Exclusion Criteria:

• Contraindications for contraceptive steroids.

• In accordance with the Summary of Product Characteristics (SmPC)/Package Insert of DRSP-EE, additional

contraindications related to the antimineralocorticoid activity of drospirenone

(conditions that predispose to hyperkalemia):

• Renal insufficiency

• Hepatic dysfunction

• Adrenal insufficiency

• An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia [CIN],

Squamous Intraepithelial Lesion [SIL], carcinoma in situ, invasive carcinoma) at screening.

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

• Use of an injectable hormonal method of contraception; within 6 months of an injection with a 3-month duration, within 4 months of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration.

• Before spontaneous menstruation has occurred following a delivery or abortion.

• Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication.

• Present use or use within 2 months prior to the 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 posttreatment contraceptive method) and herbal remedies containing Hypericum perforatum (St John's Wort).

• Administration of 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.