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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

Study Summary

This trial aims to find an effective emergency contraceptive option for people with overweight or obesity.

Eligible Conditions
  • Birth Control

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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured daily for the seven days immediately following administration of the drospirenone-only pill dose during the intervention cycle (cycle length 21-35 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dominant ovarian follicle ultrasound measurement
Serum progesterone concentration
Secondary outcome measures
Serum potassium concentration

Side effects data

From 2017 Phase 3 trial • 1552 Patients • NCT02269241
5%
Metrorrhagia
5%
Headache
4%
Breast pain
4%
Dysmenorrhoea
4%
Nausea
3%
Breast tenderness
3%
Acne
2%
Menorrhagia
2%
Weight increased
1%
Vaginal haemorrhage
1%
Amenorrhoea
1%
Abdominal distension
1%
Vomiting
1%
Migraine
1%
Alopecia
1%
Mood swings
1%
Menstruation irregular
1%
Abdominal pain
1%
Depression
1%
Affect lability
1%
Vulvovaginal mycotic infection
1%
Decreased appetite
1%
Libido decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Drospirenone 4mg

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
1,734 Previous Clinical Trials
2,148,848 Total Patients Enrolled

Media Library

Drospirenone-only pill (Progestin-only pill) Clinical Trial Eligibility Overview. Trial Name: NCT05675644 — Phase 2
Birth Control Research Study Groups: Dose finding, Primary ovulation inhibition testing
Birth Control Clinical Trial 2023: Drospirenone-only pill Highlights & Side Effects. Trial Name: NCT05675644 — Phase 2
Drospirenone-only pill (Progestin-only pill) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05675644 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~16 spots leftby Apr 2025