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Progestin-only pill
Drospirenone-only pill for Emergency Contraception
Phase 2
Waitlist Available
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured daily for the seven days immediately following administration of the drospirenone-only pill dose during the intervention cycle (cycle length 21-35 days)
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if a single dose of drospirenone can prevent ovulation in women who are overweight or obese. Current emergency contraceptives don't work as well for these women, so this study aims to find a better option. Drospirenone is a new type of hormone that has been shown to stop ovulation and is used in various contraceptive methods.
Eligible Conditions
- Birth Control
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured daily for the seven days immediately following administration of the drospirenone-only pill dose during the intervention cycle (cycle length 21-35 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured daily for the seven days immediately following administration of the drospirenone-only pill dose during the intervention cycle (cycle length 21-35 days)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dominant ovarian follicle ultrasound measurement
Serum progesterone concentration
Secondary study objectives
Serum potassium concentration
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Primary ovulation inhibition testingExperimental Treatment1 Intervention
Drospirenone-only pill single-dose at dose determined by dose finding arm
Group II: Dose findingExperimental Treatment1 Intervention
Drospirenone-only pill single-dose ranging from 16mg to 32mg
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,802 Previous Clinical Trials
2,822,077 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have unexplained or abnormal bleeding from your uterus or genitals that has not been diagnosed.You have a kidney condition or take certain medications that can affect your kidney function or electrolyte balance.You are planning to lose a lot of weight during the study, either through surgery, dieting, or other reasons.You are in good overall health.You have a current problem with alcohol or use illegal drugs that may interfere with how the drospirenone medication works in your body.Your thyroid disorder is not under control.
Research Study Groups:
This trial has the following groups:- Group 1: Dose finding
- Group 2: Primary ovulation inhibition testing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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