Efficacy, Safety, and Acceptability of Mifepristone 50 mg Once-weekly as a Contraceptive

Female Contraception Clinical Trial

— WOMEN  

Official title:

Prospective Phase III Multi-center Open-label Study of the Efficacy, Safety, and Acceptability of Mifepristone 50 mg Once-weekly as a Contraceptive

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06394999
• Other study ID #: 2022-502694-41-00
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 2024
• Est. completion date: September 2029

Study information

• Verified date: April 2024
• Source: Leiden University Medical Center
• Contact: Rebecca Gomperts, PhD
• Phone: +31652052561
• Email: r.gomperts[@]lumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Participants in the study will use mifepristone 50 mg once-a-week for one year as a contraceptive. With this, we want to confirm that the chances of getting pregnant while using this contraceptive are very small. We also want to demonstrate that the use of mifepristone is safe, and it does not lead to any severe health problems. We expect fewer side effects compared to other frequently used contraceptives with hormones. Mifepristone does not contain these hormones. It is important to know how people experience that use of one tablet a week.

Description:

Mifepristone 50 mg, a progesterone receptor modulator, is a proven safe emergency contraceptive and a promising new weekly contraceptive. As mifepristone does not contain estrogens or progestogens, we anticipate users will not experience the undesirable side effects and health risks of current hormonal contraceptives. Furthermore, pills are a highly desired formulation approach and a weekly regimen instead of daily administration will likely contribute to a high acceptability and adherence among users. Based on promising early stage clinical data, we expect the use of weekly mifepristone 50 mg as a contraceptive will be safe, effective, and acceptable.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1186
• Est. completion date: September 2029
• Est. primary completion date: September 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

1. Age 18-35

2. Live in the Netherlands and speak and understand Dutch or English

3. No desire to become pregnant within the following 12 months, be willing to use mifepristone as the on-ly method of contraception for 12 months.

4. Expecting to have unprotected vaginal heterosexual intercourse with a non-sterilized partner at least once a month.

5. A menstrual cycle of 21-35 days when not using hormonal contraceptives

6. After depo-provera (3 month injectable) at least 3 cycles of 21-35 days

7. BMI < 35 kg/m2

8. Be able to take oral medication and be willing to adhere to the study protocol.

9. Be willing to fill in a daily dairy

10. Be able to participate in the scheduled visits

11. If 30 years or older, prior Human Papilloma Virus (HPV) or pap-test

12. Be willing to provide signed and dated informed consent about participating in study

Exclusion Criteria:

1. Currently pregnant or breast-feeding

2. Signs of current endometritis, incomplete abortion after miscarriage or induced abortion, or retained placental rests after delivery.

3. Undiagnosed post-coital bleeding or unscheduled bleeding (spotting with Combined Oral Contraceptive (COC), patch, vaginal ring, hormonal Intrauterine Device (IUD), implant or hormonal injection allowed)

4. Known subfertility or history of ectopic pregnancy, unless intra-uterine pregnancy afterwards

5. History of gastric bypass

6. Previous or current liver illness, previous or current infection affecting the liver (such as Hepatitis C) or abnormal liver enzymes at screening.

7. Current or previous cancer

8. Family history of endometrial cancer, except BReast CAncer (BRCA) genome mutation

9. Known allergy to mifepristone.

10. Using oral 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)

11. Treatment with another investigational drug or participating in another intervention study

12. Undiagnosed reason for severe anemia or increased creatinine

13. Abnormal previous Papanicolaou (PAP) smear > pap II without colposcopic evaluation or untreated High grade Squamous Intraepithelial Lesion (HSIL)

14. Blood pressure 180 or more systolic and/or 110 diastolic or more at screening (hypertension with medical treatment allowed)

15. Intracavitary abnormalities on vaginal ultrasound at screening, including intracavitary polyps or myomas, irregular cystic endometrium, endometrium > 15 mm, or an obvious sign of hydrosalpinx

16. Unable to comply with the trial protocol

Related Conditions & MeSH terms

• Female Contraception

Intervention

Drug:
• Mifepristone 50 mg
Once-weekly oral mifepristone 50 mg

Locations

Country	Name	City	State
Netherlands	Ziekenhuisgroep Twente	Almelo
Netherlands	Amsterdam Universitair Medische Centra	Amsterdam
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Martini Ziekenhuis	Groningen
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Diakonessenhuis	Utrecht

Sponsors (4)

Lead Sponsor	Collaborator
Leiden University Medical Center	Children's Investment Fund Foundation, Karolinska Institutet, Women on Waves

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the contraceptive efficacy of once-weekly mifepristone 50 mg	Occurrence of pregnancy during treatment caused by user and method failure (Overall Pearl Index)	12 months
Primary	To assess the contraceptive safety of once-weekly mifepristone 50 mg	Proportion of women with endometrial thickness >15 mm, endometrium with irregular cystic appearance on US; with ALT, AST elevation three times above normal levels or bilirubin two times above normal levels; with adverse events / serious adverse events	3, 6 and 12 months
Secondary	To assess acceptability of once-weekly mifepristone 50 mg	User failure; Depression; Sexual functioning; Use of antidepressants; Weight changes; Bleeding profile; Side effects; Acceptability	3, 6 and 12 months
Secondary	Exploration of pregnancy outcomes	The proportion of women either opting for an abortion or opting for continuing the pregnancy. In case of continuation: outcomes of pregnancies such as miscarriages, ectopic pregnancies, preterm labor, growth restriction and congenital abnormalities will be registered.	21 months
Secondary	Exploration of temporary increased liver functions	Figures about liver functions below 3 x Upper Limit Normal (ULN) (ALT/AST) or below 2 x ULN (bilirubin) are unknown, as time to normalization.	3, 6 and 12 months