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Drospirenone-only pill for Emergency Contraception
Study Summary
This trial aims to find an effective emergency contraceptive option for people with overweight or obesity.
- Birth Control
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 3 trial • 1552 Patients • NCT02269241Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Dose finding
- Group 2: Primary ovulation inhibition testing
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
To what extent is dose finding hazardous to individuals?
"Due to its Phase 2 designation, our team has assigned Dose Finding a safety score of 2, indicating that there is some data available supporting the medication's security but no clinical proof for efficacy."
Who has the ability to qualify for this experiment?
"This clinical trial is offering 35 slots to participants aged 18-35 who are taking birth control. Some of the key eligibility requirements include having a body mass index (BMI) less than 30 kg/m2, possessing an intact uterus with at least 1 ovary, passing a negative urine pregnancy test both during screening and when drospirenone is administered, using barrier contraception or other non-hormonal methods throughout the study period, confirming ovulation via progesterone level testing that should be higher than 3ng/ml during screening visits, being in good general health overall, and meeting age criteria."
Are senior citizens excluded from enrollment in this clinical research?
"This clinical trial is only open to candidates between the ages of 18 and 35. For younger patients, there are 59 studies available whereas those over 65 have 171 options at their disposal."
Is the recruitment stage of this clinical trial still ongoing?
"Contradictorily, the information hosted on clinicaltrials.gov indicates that this medical trial is not accepting recruits. Initially posted in February of 2023 and last updated in December 2022, it appears to have reached its recruitment goals as there are now 241 other trials actively looking for participants."
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