Status:
UNKNOWN
A proof-of Concept, Randomized 3-month Study to Evaluate the Effects of Three Contraceptive Intrauterine Systems Delivering Copper and a Daily Dose of 5, 20 or 40 μg of Ulipristal Acetate (UPA)
Lead Sponsor:
Population Council
Conditions:
Contraception
Eligibility:
FEMALE
21-38 years
Phase:
PHASE1
Brief Summary
The UPA doses to be tested in this new IUS, 5, 20 or 40 μg per day, are not expected to suppress ovulation, however they should prevent endometrial growth resulting in endometrial atrophy, minimal ble...
Detailed Description
Intrauterine devices (IUD) such as the Copper IUD (Paragard) and the levonorgestrel (LNG) IUS (Mirena®) are considered highly safe and effective long acting reversible methods of contraception (LARC)....
Eligibility Criteria
Inclusion
- Healthy women of reproductive age (21-38 years)
- Not at risk for pregnancy based on subject has undergone sterilization or subject is monogamous and her male partner has undergone sterilization
- Have regular menstrual cycles of 21-35 days duration
- Have an intact uterus and both ovaries
- Will be able to comply with the protocol
- Capable of giving informed consent
Exclusion
- Women participating in another clinical trial within 30 days of initiation of this clinical trial
- Women not living in the catchment area of the clinic
- Known hypersensitivity to progestins or antiprogestins
- Known hypersensitivity to copper
- Any known chronic disease including HIV/AIDS
- All contraindications to IUD use,
- Desire to get pregnant during the study Breastfeeding
- Undiagnosed vaginal discharge or vaginal lesions or abnormalities
- Women with a current abnormal Pap. In accordance with the Bethesda system of classification: smear suggestive of high-grade pre-cancerous lesion(s), including HGSIL, are excluded;
- Women with LGSIL or ASCUS/high-risk HPV positive may participate if further evaluated with colposcopy and biopsy and no evidence of a lesion with a severity \> CIN I is present and/or endocervical curettage is negative.
- Women with a biopsy finding of CIN I should have follow up for this finding per standard of care; women are excluded it treatment is indicated.
- Known benign or malignant liver tumors; known active liver disease
- Cancer (past history of any carcinoma or sarcoma)
- Medically diagnosed severe depression currently or in the past
- Known or suspected alcoholism or drug abuse
- Abnormal, clinically significant, serum fasting clinical chemistry values
- Women with known abnormal thyroid status
- Women with known impaired hypothalamic-pituitary-adrenal reserve
- Average diastolic BP \> 85 mm or systolic BP \>135 mm Hg after 5-10 minutes rest
- Body mass index (BMI) \> 30.0 (or ≤18) Kg/m2
- Women with uterine anomalies
- Use within the past 2 months of any implanted hormonal contraceptives including progestin-releasing intrauterine systems (IUS) or progestin-releasing subdermal implants. NOTE: Removal of implanted hormonal contraceptives must have been for personal reasons unrelated to the purpose of enrollment in this study.
- Current use of a non-hormone containing IUD. NOTE: Removal of an IUD must be for personal reasons unrelated to the purpose of enrollment in this study.
- Use of injectable contraceptives during the previous 3 months (e.g. Cyclofem) or 6 months (e.g. DMPA).
- Women who do not have at least two progesterone measurements ≥10nmol/L during the baseline cycle will be excluded from further participation in the study (See Section 13.4.1)
- Acute pelvic inflammatory disease or a history of pelvic inflammatory disease unless there has been a subsequent intrauterine pregnancy. Postpartum endometritis or infected abortion in the past 3 months.
- Genital bleeding of unknown etiology.
- Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled.
- Current behavior suggesting a high risk for pelvic inflammatory disease
- Mucopurulent cervicitis
- Wilson's disease
- Allergy to any component of the IUS
Key Trial Info
Start Date :
May 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03230539
Start Date
May 1 2017
End Date
May 1 2018
Last Update
August 15 2017
Active Locations (1)
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1
Profamilia
Santo Domingo, Dominican Republic