Prevention of unwanted pregnancy Pregnancy and Childbirth Prevention of unwanted pregnancy
Conditions
Interventions
Current interventions as of 10/10/2023:
All participants will self-administer one Ginestril 50 mg tablet (mifepristone 50 mg) per week orally for a duration of 15 menstrual cycles, or until its ter
Sponsors
Women on Waves
Eligibility
Sex/Gender
Female
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1. No desire to become pregnant within the next 13 months 2. Provision of signed and dated informed consent form for participation in the study 3. Willing to comply with all study procedures and available for the duration of the study 4. Aged between 18 and 35 years 5. Have a normal menstrual cycle length between 25 and 35 days 6. At least one normal menstrual cycle after miscarriage or abortion and no abnormal blood loss 7. Willing to engage in at least three acts of penis-in-vagina sexual intercourse per month 8. Willing to use the study drug as the only method of contraception over the course of the study. If the potential participant is taking another contraceptive, they would have to stop and have one menstruation to be included in the trial. 9. Able to take oral medication and be willing to adhere to the contraceptive regimen
Exclusion criteria
Exclusion criteria: 1. Current pregnancy 2. Within 3 months of delivery 3. Abnormal cervical smear or within the year before 4. Known infertility or subfertility 5. History of ectopic pregnancy 6. Any previous or current malignancy including breast cancer 7. Abnormal liver enzymes 8. Irregularities in the endometrium 9. Retained products of conception after miscarriage or abortion 10. Signs of endometritis 11. Known allergic reactions to mifepristone 12. Lactation 13. Using high doses of corticosteroids or any drugs that may interact with mifepristone including hydantoins (e.g. phenytoin), barbiturates (e.g. phenobarbital), primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, rifabutin, felbamate, ritonavir, nelfinavir, griseofulvin, and products containing St. John's wort (Hypericum perforatum) 14. Treatment with another investigational drug 15. Unable to comply with the trial protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 10/10/2023: 1. Occurrence of pregnancy during treatment 2. Endometrial changes 3. SEA's _____ Previous primary outcome measure: 1. Occurrence of pregnancy during treatment caused by method failure measured using the following: 1.1. Participant administered urine hCG pregnancy tests every 4 weeks between baseline and 15 months 1.2. Investigator administered urine hCG pregnancy tests at baseline, 3, 6, 9, 13, and 15 months 1.3. Vaginal ultrasound at baseline, 3, 6, 9, 13, and 15 months 1.4. Self-reporting of adherence in participant diaries between baseline and 13 months 2. Proportion of women with endometrium thickness >15 mm and/or an endometrium with an irregular cystic appearance measured using vaginal ultrasound at baseline, 3, 6, 9, 13, and 15 months 3. Proportion of women with ALAT, ASAT, and bilirubin elevation three times above normal measured using blood tests at baseline, 3, 6, 9, 13, and 15 months 4. Proportion of women with adverse events and serious adverse events from case report forms completed by investigators between baseline and 15 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 10/10/2023: Acceptablility ____ Previous secondary outcome measures: 1. Occurrence of pregnancy during treatment caused by user failure measured using the following: 1.1. Participant administered urine hCG pregnancy tests every 4 weeks between baseline and 15 months 1.2. Investigator administered urine hCG pregnancy tests at baseline, 3, 6, 9, 13, and 15 months 1.3. Vaginal ultrasound at baseline, 3, 6, 9, 13, and 15 months 1.4. Self-reporting of adherence in participant diaries between baseline and 13 months 2. Proportion of women with blood hormone levels abnormalities measured using blood test at baseline, 3, 6, 9, 13, and 15 months 3. Proportion of women with endometrial changes (PAEC) confirmed by endometrial biopsy at baseline, 3, 6, 9, 13, and 15 months 4. Proportion of women with normal haemoglobin value measured using blood tests at baseline, 3, 6, 9, 13, and 15 months 5. Quality of life measured using the mean value of the EuroQol 5-dimension quality of life questionnaire (EQ-5D-5L) at baseline, 3, 6, 9, 13, and 15 months 6. Proportion of women who uses antidepressants measured from participant diaries between baseline and 15 months 7. Proportion of women with dysmenorrhea measured from participant diaries between baseline and 15 months 8. Proportion of women with acne occurrence measured from participant diaries between baseline and 15 months 9. Proportion of women with side-effects (such as headache, nausea, breast pain, dry eyes) measured from participant diaries between baseline and 15 months 10. Weight measured using a scale at baseline, 3, 6, 9, 13, and 15 months 11. Proportion of women with vaginal bleeding measured from participant diaries between baseline and 15 months 12. Libido measured using the mean value of Female Sexual Function Index (FSFI) at baseline, 3, 6, 9, 13, and 15 months | — |
Countries
Moldova
Contacts
Public ContactRebecca Gomperts
Outcome results
None listed