Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens

Launched by GYNUITY HEALTH PROJECTS · Jul 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different medication regimens to help women who have missed their period and want to induce their menstrual cycle. The trial aims to find out how effective and acceptable these treatments are when taken 2 to 8 days after a missed period. One treatment involves taking one dose of a medication called levonorgestrel, followed by another medication called mifepristone a day or two later. The other treatment uses a placebo (a pill with no active medication) before taking mifepristone. Researchers will compare how many women in each group are not pregnant at follow-up visits.

To participate in this trial, women aged 15 to 49 who are generally healthy, have regular menstrual cycles, and do not want to be pregnant may be eligible. They should have missed their period for 2 to 8 days and been sexually active in the past month. Participants will need to sign consent forms, provide urine samples, and return for follow-up visits. It’s important to note that women with certain medical conditions or who are using specific forms of birth control may not be able to join the trial.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Age 15-49 years
• • General good health
• • Does not want to be pregnant
• • History of regular monthly menstrual cycles (+/- 3 days)
• • Missed menses of 2 to 8 days
• • Sexual activity in the past month
• • Willing and able to sign consent forms
• • Willing to return for a follow-up visit
• • Willing to provide urine sample at enrollment and follow-up
• Exclusion Criteria:
• • Known allergies or contraindications to either study drug
• • Symptoms or risk factors for ectopic pregnancy
• • Current use of an IUD, contraceptive implant or injectable