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

NCT ID: NCT02852681

Last Updated: 2016-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-04-30

Brief 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.

Detailed Description

Food effect bioavailability studies are usually conducted for new drugs and drug products to assess the effect of food on the rate and extent of absorption of a drug when the drug product is administered shortly after a meal (fed conditions), as compared to administration under fasting conditions. Therefore, this study was designed to characterize the effect of a high fat meal on the bioavailability of E4 and DRSP after administration of a single tablet containing 15 mg E4 and 3 mg DRSP.

All subjects entered the study site at least 12 hours before each dosing and fasted for at least 10 hours prior to each dose.

All subjects were to receive both Treatment A (Reference; a single 15 mg E4/3 mg DRSP tablet without food (fasted)) and Treatment B (Test; a single 15 mg E4/3 mg DRSP tablet with food (fed)) either at the first treatment period (Period 1) or the second treatment period (Period 2). Approximately half of the subjects were randomized to receive either Treatment A followed by Treatment B (Sequence AB), or Treatment B followed by Treatment A (Sequence BA).

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

15 mg E4/3 mg DRSP without food

Treatment A (Reference): a single 15 mg E4/3 mg DRSP tablet without food (fasted).

Group Type: OTHER

15 mg E4/3 mg DRSP

Intervention Type: DRUG

All subjects received both Treatment A and Treatment B either at the first treatment period (Period 1) or the second treatment period (Period 2). Approximately half of the subjects was randomized to receive either Treatment A followed by Treatment B (Sequence AB), or Treatment B followed by Treatment A (Sequence BA)

15 mg E4l/3 mg DRSP with food

Treatment B (Test): a single 15 mg E4/3 mg DRSP tablet with food (fed)

Group Type: OTHER

15 mg E4/3 mg DRSP

Intervention Type: DRUG

All subjects received both Treatment A and Treatment B either at the first treatment period (Period 1) or the second treatment period (Period 2). Approximately half of the subjects was randomized to receive either Treatment A followed by Treatment B (Sequence AB), or Treatment B followed by Treatment A (Sequence BA)

Interventions

15 mg E4/3 mg DRSP

All subjects received both Treatment A and Treatment B either at the first treatment period (Period 1) or the second treatment period (Period 2). Approximately half of the subjects was randomized to receive either Treatment A followed by Treatment B (Sequence AB), or Treatment B followed by Treatment A (Sequence BA)

Intervention Type: DRUG

Other Intervention Names

15 mg Estetrol/3 mg Drospirenone

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Estetra

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dobrin Sviranov, MD

Role: PRINCIPAL_INVESTIGATOR

Comac Medical

Other Identifiers

2015-001764-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Es0001-C101

Identifier Type: -

Identifier Source: org_study_id