- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03230539
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)
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) on Ovulation, Endometrial Changes and Bleeding Patterns in Normally Cycling Women
Study Overview
Status
Conditions
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). Nevertheless discontinuations are high due to user complaints of heavy bleeding during the first few months after insertion of IUDs or irregular bleeding in the first year of use of an IUS. To prevent these bleeding problems and enhance the overall safety profile, a new IUS is being developed that will deliver copper to provide its well described contraceptive efficacy in combination with UPA, a progesterone receptor modulator (PRM) that may decrease the amount of bleeding associated with use of a Cu IUD.
Since results of human studies delivering antiovulatory doses of UPA orally or with vaginal rings have shown endometrial changes characterized as typical PAECs, the occurrence of these endometrial effects with lower doses of the PRM delivered in the endometrium via this investigational IUS requires evaluation with both histology assessments and measures of proliferation markers. We need to determine if small doses of UPA administered locally with a new Cu-IUS with UPA can result in reduced bleeding or amenorrhea, as observed in the monkey study, and whether or not endometrial modifications occur.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Ruth Merkatz, RN
- Phone Number: 212-327-8647
- Email: rmerkatz@popcouncil.org
Study Locations
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-
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Santo Domingo, Dominican Republic
- Recruiting
- Profamilia
-
Contact:
- Vivian Brache, Lic.
- Phone Number: 809-681-8357
- Email: biomedica@codetel.net.do
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Principal Investigator:
- Vivian Brache, Lic.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: UPA IUS 20 μg
This is a proof-of-concept study utilizing a randomized dose-finding, parallel design to assess the effects of an IUS delivering Cu and 5, 20, or 40 μg of UPA over 12 weeks.
|
This is a proof-of-concept study utilizing a randomized dose-finding, parallel design to assess the effects of an IUS delivering Cu and 5, 20, or 40 μg of UPA over 12 weeks.
|
Experimental: UPA IUS 5 μg
This is a proof-of-concept study utilizing a randomized dose-finding, parallel design to assess the effects of an IUS delivering Cu and 5, 20, or 40 μg of UPA over 12 weeks
|
This is a proof-of-concept study utilizing a randomized dose-finding, parallel design to assess the effects of an IUS delivering Cu and 5, 20, or 40 μg of UPA over 12 weeks.
|
Experimental: UPA IUS 40 μg
This is a proof-of-concept study utilizing a randomized dose-finding, parallel design to assess the effects of an IUS delivering Cu and 5, 20, or 40 μg of UPA over 12 weeks
|
This is a proof-of-concept study utilizing a randomized dose-finding, parallel design to assess the effects of an IUS delivering Cu and 5, 20, or 40 μg of UPA over 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary endpoint is the ability of the three doses of UPA as delivered by IUS to suppress bleeding.
Time Frame: 12 weeks
|
Bleeding data obtained from diaries and CRFs.
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ruth Merkatz, RN, Population Council
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 719
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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