Prevention of unwanted pregnancy
Conditions
Interventions
Trade Name: Ginestril 50mg tablets
Product Name: Ginestril 50mg Tablets
Pharmaceutical Form: Tablet
Sponsors
Women on Web International Foundation
Eligibility
Sex/Gender
All
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. stated willingness to comply with all study procedures and availability for the duration of the study 4. female, aged 18-35 5. have a normal menstrual cycle of 25-35 days cycles which differ by no more than 3 days with less than 7 days of bleeding 6. at least one normal menstrual cycle after miscarriage or abortion and no abnormal blood loss 7. be willing to engage in at least three acts of penis-in-vagina sexual intercourse per month 8. be 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. ability to take oral medication and be willing to adhere to the contraceptive regimen Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 949 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. current pregnancy 2. within 3 months of delivery 3. abnormal cervical smear or within 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 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 - these include 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 |
|---|---|
| Main Objective: To assess the contraceptive efficacy and safety of once a week mifepristone 50 mg.;Secondary Objective: To determine the side-effects and acceptability of once a week mifepristone 50 mg.;Timepoint(s) of evaluation of this end point: As indicated above;Primary end point(s): 1. Occurrence of pregnancy during treatment caused by method failure. 2. Proportion of women with endometrium thickness>15 mm, endometrium with irregular cystic appearance on US at baseline months 3, 6, months 9, months 13 and 2 months after end of treatment. 3. Proportion of women with ALAT, ASAT and bilirubin elevation three times above normal at baseline, months 3, months 6, months 9, months 13 and 2 months after end of treatment. 4. Proportion of women with adverse event / serious adverse event. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Occurrence of pregnancy during treatment caused by user failure. 2. Proportion of women with blood hormone levels abnormalities. 3. Proportion of women with anovulatory cycles. 4. Proportion of women with endometrial changes (PAEC) confirmed by biopsy at baseline, months 3, months 6, months 9 and 2 months after end of treatment. 5. Proportion of women with normal haemoglobin value at baseline, 3 months, 6 months, 9 months, 13 months and 2 months after end of treatment. 6. Mean value of quality of life questionnaire (EQ-5D-5L) at baseline, 3 months, 6 months, 9 months, 13 months and 2 months after end of treatment. 7. Proportion of women who uses antidepressants at baseline and during the study. 8. Proportion of women with dysmenorrhea (diary continued measurement) during the study. 9. Proportion of women with acne occurrence (diary continued reporting) during the study. 10. Proportion of women with side-effects (headache, nausea, breast pain, dry eyes) (diary continued reporting) during the study. 11. Mean weight changes at 3 months, 6 months, 9 months, 13 months and 2 months after end of treatment compared to baseline. 12. Proportion of women with vaginal bleeding (diary continued measurement) 13. Libido: mean value of Female Sexual Function Index (FSFI) at baseline, 3 months, 6 months, 9 months and 2 months after end of treatment. ;Timepoint(s) of evaluation of this end point: As indicated above | — |
Countries
Georgia
Contacts
Public ContactRebecca Gomperts
Women on Waves
Outcome results
None listed