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

NCT02852681 | Completed Phase 1

• 2 other identifiers: Es0001-C1012015-001764-19
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Contraception

Outcome Measures

Primary Outcomes (6)

• Maximum concentration (Cmax) of estetrol in plasma

  PK sampling

  From day 1 to 4 during both period 1 and period 2

• Cmax of drospirenone in plasma

  PK sampling

  From day 1 to 4 during both period 1 and period 2

• Area under the plasma concentration versus time curve from time 0 to the last determined concentration (AUC0-tdlc) of estetrol

  From day 1 to 4 during both period 1 and period 2

• AUC0-tdlc of drospirenone

  From day 1 to 4 during both period 1 and period 2

• AUC0-inf of estetrol

  PK sampling

  Day 1 to 4 during both period 1 and period 2

• AUC0-inf of drospirenone

  PK sampling

  Day 1 to 4 during both period 1 and period 2

Secondary Outcomes (1)

• Number of subjects with adverse events as a measure of safety and tolerability

  From up to day 28 before randomization (28 day screening/run-in period) to day 4 of the Period 2

Study Arms (2)

15 mg E4/3 mg DRSP without food

OTHER

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

Drug: 15 mg E4/3 mg DRSP

15 mg E4l/3 mg DRSP with food

OTHER

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

Drug: 15 mg E4/3 mg DRSP

Interventions

15 mg E4/3 mg DRSP 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)

Also known as: 15 mg Estetrol/3 mg Drospirenone

15 mg E4/3 mg DRSP without food; 15 mg E4l/3 mg DRSP with food

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Estetra: lead

Study Officials

• Dobrin Sviranov, MD

  Comac Medical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: August 2, 2016
• Study Start: August 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: April 1, 2016
• Last Updated: August 2, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share