Effect of Food on the Bioavailability of 15 mg Estetrol/3 mg Drospirenone Tablets in Healthy Female Volunteers

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

This single-center, open-label, randomized, balanced, single-dose, two-treatment, two-period, two-sequence crossover study was conducted under medical supervision in 28 healthy female volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Estetra
• Treatments: Drospirenone

Criteria

Inclusion Criteria:

• Overtly healthy females.

• Between the ages of 18 and 45 years, inclusive.

• Non-smokers who have not used tobacco or nicotine in any form during the 3 months prior to the screening visit.

• Between the body mass index (BMI) of 18 and 30 kg/m2, inclusive, and body weight 45kg.

• Negative serum pregnancy test results at screening and negative urine pregnancy test results before dosing.

• Willing to use double-barrier methods of non-hormonal contraception during the entire study period.

Exclusion Criteria:

Potential study subjects were not entered into and/or may have been discontinued from the study if any of the following applied:

• Use of

• progestogen-only contraceptive methods [e.g., minipill, implant or, intrauterine system (IUS)] during the last 3 months prior to the first dose or,

• depot progestogen preparations or an injectable hormonal method of contraception (e.g., Depo-Provera) during the last 6 months prior to the first dose.

• Use (within 28 days prior to first dose) of other hormonal contraceptive method.

• Use of

• any prescription drugs (except thyroid hormone supplements) or herbal supplements acting on CYP3A4 functions (e.g., St. John's Wort), within 28 days prior to the first dose until study completion,

• any over-the-counter (OTC) medication (including paracetamol) or dietary supplements (vitamins included) within 14 days prior to the first study dose until study completion.