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Drospirenone-only Pill as Emergency Contraception

Primary Purpose

Contraception

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Drospirenone-only pill
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Contraception focused on measuring drospirenone, emergency contraception

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Overall good general health. Age 18-35 years at time of enrollment. BMI 1. Initial dose-finding cohort: BMI < 30 kg/m2; thereafter no BMI limit Intact uterus with at least 1 ovary. Regular menstrual cycles that occur every 21-35 days: If patient is postpartum or post-second trimester abortion, she must have 3 menses (2 cycles) prior to enrollment. If patient had a first trimester abortion or pregnancy loss, she must have one spontaneous menses prior to enrollment. Negative urine pregnancy test at screening visit and at time of drospirenone administration. Consistent use of a barrier method or other non-hormonal birth control method throughout the study, or otherwise not at risk for pregnancy. Ovulatory as confirmed by a documented screening progesterone (P4) level ≥3ng/ml at screening visit. Willingness and ability to abstain from medications and supplements known to induce/inhibit CYP3A4 during the study period Willingness and ability to comply with the protocol requirements. Lives within the study site catchment area or within a reasonable distance from the site. Exclusion Criteria: Have a known hypersensitivity or contraindications to drospirenone. Currently taking any known CYP3A4 inducers/inhibitors. Medical conditions that affect liver function (e.g., hepatitis, cirrhosis; assessed via participant self-report). Medical conditions that affect kidney function (e.g., chronic kidney disease, primary renal disease; assessed via participant self-report) or use of medications that can affect kidney function and/or electrolyte balance (e.g., ACE inhibitors, diuretic medications; assessed via participant self-report). A known history of or presence of hyperkalemia (potassium ≥4.5mEq/L) or renal impairment (creatinine of ≥1.1mg/dL) at screening visit. Known or suspected current alcohol dependence syndrome or any illicit drug use that may affect the metabolism of the drospirenone. Undiagnosed abnormal uterine/genital bleeding. Uncontrolled thyroid disorder. Use of long-acting injectable hormonal contraceptive within the past 6 months prior to enrollment unless the patient has had at least one spontaneous menstrual cycle since the last injection. Recent use of hormonal oral, patch, intravaginal, or intrauterine contraception unless that patient has had at least one spontaneous menstrual cycle since discontinuation. Currently breastfeeding or are within 30 days of discontinuing breastfeeding unless the patient has already had a menses following discontinuation. Planning on undergoing major surgery during study participation. Planning significant weight loss during the study related to bariatric surgery, dieting, or other causes. Planning pregnancy during their anticipated months of study participation

Sites / Locations

  • University of Colorado Denver

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dose finding

Primary ovulation inhibition testing

Arm Description

Drospirenone-only pill single-dose ranging from 16mg to 32mg

Drospirenone-only pill single-dose at dose determined by dose finding arm

Outcomes

Primary Outcome Measures

Serum progesterone concentration
Serum progesterone concentration measured after drug administration
Dominant ovarian follicle ultrasound measurement
Measurement of the dominant ovarian follicle in three planes (width, length, height) using transvaginal ultrasound

Secondary Outcome Measures

Serum potassium concentration
Measured as a safety outcome

Full Information

First Posted
December 12, 2022
Last Updated
December 21, 2022
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT05675644
Brief Title
Drospirenone-only Pill as Emergency Contraception
Official Title
Drospirenone for Emergency Contraception: a Dose-finding Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Emergency contraception (EC) provides an additional measure to help prevent pregnancy after unprotected intercourse or contraceptive failure. The two currently available oral emergency contraceptive methods, levonorgestrel (LNG) and ulipristal acetate (UPA), have differing availability and effectiveness. Overweight and obesity are strong risk factors for failure of EC containing LNG and UPA for body mass index (BMI) ≥ 26kg/m2 and ≥35kg/m2, respectively, resulting in limited EC options for much of the population. Drospirenone is a unique progestin that effectively inhibits ovulation when taken daily as progestin-only oral contraception and has pharmacokinetic properties that make it a good candidate for a novel effective emergency contraceptive method across BMI categories. The investigators propose a dose-finding, adaptive-design pilot study evaluating if a single dose of drospirenone can inhibit ovulation prior to the luteinizing hormone (LH) surge. The dose-finding study design will be conducted in a well-established 3+3 model with 2 planned study arms stratified by BMI. The investigators hypothesize that a single dose of drospirenone will effectively inhibit ovulation when administered prior to the LH surge. This pilot data will directly support the dose selection for future research further evaluating the efficacy of drospirenone-only EC aimed at ultimately increasing oral EC options, particularly for patients with overweight or obesity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contraception
Keywords
drospirenone, emergency contraception

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
3x3 adaptive dose-finding design
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose finding
Arm Type
Experimental
Arm Description
Drospirenone-only pill single-dose ranging from 16mg to 32mg
Arm Title
Primary ovulation inhibition testing
Arm Type
Experimental
Arm Description
Drospirenone-only pill single-dose at dose determined by dose finding arm
Intervention Type
Drug
Intervention Name(s)
Drospirenone-only pill
Intervention Description
Single dose based on adaptive dose-finding design
Primary Outcome Measure Information:
Title
Serum progesterone concentration
Description
Serum progesterone concentration measured after drug administration
Time Frame
Measured daily for the seven days immediately following administration of the drospirenone-only pill dose during the Intervention cycle (each cycle is 21-35 days)
Title
Dominant ovarian follicle ultrasound measurement
Description
Measurement of the dominant ovarian follicle in three planes (width, length, height) using transvaginal ultrasound
Time Frame
Measured daily for the seven days immediately following administration of the drospirenone-only pill dose during the Intervention cycle (cycle length 21-35 days)
Secondary Outcome Measure Information:
Title
Serum potassium concentration
Description
Measured as a safety outcome
Time Frame
Measured on the first and second days immediately following administration of the drospirenone-only pill dose during the Intervention cycle (cycle length 21-35 days)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Overall good general health. Age 18-35 years at time of enrollment. BMI 1. Initial dose-finding cohort: BMI < 30 kg/m2; thereafter no BMI limit Intact uterus with at least 1 ovary. Regular menstrual cycles that occur every 21-35 days: If patient is postpartum or post-second trimester abortion, she must have 3 menses (2 cycles) prior to enrollment. If patient had a first trimester abortion or pregnancy loss, she must have one spontaneous menses prior to enrollment. Negative urine pregnancy test at screening visit and at time of drospirenone administration. Consistent use of a barrier method or other non-hormonal birth control method throughout the study, or otherwise not at risk for pregnancy. Ovulatory as confirmed by a documented screening progesterone (P4) level ≥3ng/ml at screening visit. Willingness and ability to abstain from medications and supplements known to induce/inhibit CYP3A4 during the study period Willingness and ability to comply with the protocol requirements. Lives within the study site catchment area or within a reasonable distance from the site. Exclusion Criteria: Have a known hypersensitivity or contraindications to drospirenone. Currently taking any known CYP3A4 inducers/inhibitors. Medical conditions that affect liver function (e.g., hepatitis, cirrhosis; assessed via participant self-report). Medical conditions that affect kidney function (e.g., chronic kidney disease, primary renal disease; assessed via participant self-report) or use of medications that can affect kidney function and/or electrolyte balance (e.g., ACE inhibitors, diuretic medications; assessed via participant self-report). A known history of or presence of hyperkalemia (potassium ≥4.5mEq/L) or renal impairment (creatinine of ≥1.1mg/dL) at screening visit. Known or suspected current alcohol dependence syndrome or any illicit drug use that may affect the metabolism of the drospirenone. Undiagnosed abnormal uterine/genital bleeding. Uncontrolled thyroid disorder. Use of long-acting injectable hormonal contraceptive within the past 6 months prior to enrollment unless the patient has had at least one spontaneous menstrual cycle since the last injection. Recent use of hormonal oral, patch, intravaginal, or intrauterine contraception unless that patient has had at least one spontaneous menstrual cycle since discontinuation. Currently breastfeeding or are within 30 days of discontinuing breastfeeding unless the patient has already had a menses following discontinuation. Planning on undergoing major surgery during study participation. Planning significant weight loss during the study related to bariatric surgery, dieting, or other causes. Planning pregnancy during their anticipated months of study participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paige Kendall, MD
Phone
303-724-2019
Email
paige.kendall@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Dindinger, MPH
Email
eva.dindinger@cuanschutz.edu
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Dindinger
Email
eva.dindinger@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Aaron Lazorwitz, MD
First Name & Middle Initial & Last Name & Degree
Paige Kendall, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Drospirenone-only Pill as Emergency Contraception

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