ContraceptionPhase 2NCT05675644
Drospirenone-only Pill as Emergency Contraception
A Phase 2 study testing Drospirenone-only pill in people with Contraception, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Drospirenone-only pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2023to Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Eva Dindinger, MPH contact
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
Eva Dindinger, eva.dindinger@cuanschutz.edu
Aaron Lazorwitz, MD
About this study
Official title: Drospirenone for Emergency Contraception: a Dose-finding Pilot Study
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.
- Conditions
- Contraception
- Being tested
- Drospirenone-only pill
- Keywords
- drospirenone, emergency contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drospirenone-only pillDrug
Single dose based on adaptive dose-finding design
| Study group | Role | What they receive |
|---|---|---|
| Dose finding | Experimental | Drospirenone-only pill single-dose ranging from 16mg to 32mg Receives: Drug: Drospirenone-only pill |
| Primary ovulation inhibition testing | Experimental | Drospirenone-only pill single-dose at dose determined by dose finding arm Receives: Drug: Drospirenone-only pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum progesterone concentration
Serum progesterone concentration measured after drug administration
Measured: 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)
Dominant ovarian follicle ultrasound measurement
Measurement of the dominant ovarian follicle in three planes (width, length, height) using transvaginal ultrasound
Measured: 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 outcomes (1)
Serum potassium concentration
Measured as a safety outcome
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study startFeb 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 3x3 adaptive dose-finding design
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675644
- Sponsor's protocol ID
- 22-2178
- Status last verified
- Dec 2022
- First submitted
- 12 Dec 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drospirenone for Emergency Contraception: a Dose-finding Pilot Study
- ClinicalTrials.gov ID
- NCT05675644
- Acronym / sponsor ID
- 22-2178
- Conditions
- Contraception
- Keywords
- drospirenone, emergency contraception
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 3x3 adaptive dose-finding design
| Arm | Type | Receives |
|---|---|---|
| Dose finding | Experimental | Drug: Drospirenone-only pillDrospirenone-only pill single-dose ranging from 16mg to 32mg |
| Primary ovulation inhibition testing | Experimental | Drug: Drospirenone-only pillDrospirenone-only pill single-dose at dose determined by dose finding arm |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drospirenone-only pillSingle dose based on adaptive dose-finding design | Drug | Dose finding, Primary ovulation inhibition testing |
Primary outcome
Serum progesterone concentration
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)
Serum progesterone concentration measured after drug administration
Dominant ovarian follicle ultrasound measurement
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)
Measurement of the dominant ovarian follicle in three planes (width, length, height) using transvaginal ultrasound
1 secondary outcome
Serum potassium concentration
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Dindinger, MPH contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Drospirenone-only pill in people with Contraception, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paige Kendall, MD (303-724-2019, paige.kendall@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum progesterone concentration (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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.