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

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ClinicalTrials.gov Identifier: NCT02852681
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
Estetra

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.

Condition or disease Intervention/treatment Phase
Contraception Drug: 15 mg E4/3 mg DRSP Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Study to Characterize the Effect of Food on the Bioavailability of 15 mg Estetrol (E4)/3 mg Drospirenone (DRSP) Tablets in Healthy Female Volunteers
Study Start Date : August 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
15 mg E4/3 mg DRSP without food
Treatment A (Reference): a single 15 mg E4/3 mg DRSP tablet without food (fasted).
Drug: 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)
Other Name: 15 mg Estetrol/3 mg Drospirenone

15 mg E4l/3 mg DRSP with food
Treatment B (Test): a single 15 mg E4/3 mg DRSP tablet with food (fed)
Drug: 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)
Other Name: 15 mg Estetrol/3 mg Drospirenone




Primary Outcome Measures :
  1. Maximum concentration (Cmax) of estetrol in plasma [ Time Frame: From day 1 to 4 during both period 1 and period 2 ]
    PK sampling

  2. Cmax of drospirenone in plasma [ Time Frame: From day 1 to 4 during both period 1 and period 2 ]
    PK sampling

  3. Area under the plasma concentration versus time curve from time 0 to the last determined concentration (AUC0-tdlc) of estetrol [ Time Frame: From day 1 to 4 during both period 1 and period 2 ]
  4. AUC0-tdlc of drospirenone [ Time Frame: From day 1 to 4 during both period 1 and period 2 ]
  5. AUC0-inf of estetrol [ Time Frame: Day 1 to 4 during both period 1 and period 2 ]
    PK sampling

  6. AUC0-inf of drospirenone [ Time Frame: Day 1 to 4 during both period 1 and period 2 ]
    PK sampling


Secondary Outcome Measures :
  1. Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: From up to day 28 before randomization (28 day screening/run-in period) to day 4 of the Period 2 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852681


Sponsors and Collaborators
Estetra
Investigators
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Principal Investigator: Dobrin Sviranov, MD Comac Medical
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Responsible Party: Estetra
ClinicalTrials.gov Identifier: NCT02852681    
Other Study ID Numbers: Es0001-C101
2015-001764-19 ( EudraCT Number )
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Drospirenone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents