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A Study to Evaluate the Effect of a Contraceptive Vaginal Ring Delivering Ulipristal Acetate Combined With a Single or Repeated Levonorgestrel on Inhibition of Ovulation, Endometrial Changes and Bleeding Patterns in Normal Cycling Women

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ClinicalTrials.gov Identifier: NCT02451826
Recruitment Status : Unknown
Verified August 2017 by Population Council.
Recruitment status was:  Active, not recruiting
First Posted : May 22, 2015
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
Population Council

Tracking Information
First Submitted Date  ICMJE April 16, 2015
First Posted Date  ICMJE May 22, 2015
Last Update Posted Date August 15, 2017
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date November 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2015)
Pharmacodynamic efficacy as measured by the effects of a vaginal ring delivering Ulipristal acetate consistently combined with levonorgestrel administration on the endometrium [ Time Frame: 3 months ]
Endometrial biopsies (EB) will be taken as follows, a.During the follicular phase (between Day 9 and Day 12) of the baseline/control cycle, b. At the end of the 14th week of treatment (14 days after the 12 week LNG administration and end of CVR use), c. During the follicular phase (between Day 9 and Day 12 of the second menstrual cycle after ring removal). Also, endometrial changes will be measured by histological examination, immunohistochemistry, and assessment of proliferation markers (Ki67, Phospho H3 and bcl2).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02451826 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2015)
Safety as measured by number of participants with occurrence of adverse events (AEs) and concomitant medication use [ Time Frame: 3 months ]
Safety as measured by the assessment of a vaginal ring delivering Ulipristal acetate consistently combined with levonorgestrel administration
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Effect of a Contraceptive Vaginal Ring Delivering Ulipristal Acetate Combined With a Single or Repeated Levonorgestrel on Inhibition of Ovulation, Endometrial Changes and Bleeding Patterns in Normal Cycling Women
Official Title  ICMJE A Randomized Study to Evaluate the Effect of a Contraceptive Vaginal Ring Delivering a Daily Dose of 2500 μg of Ulipristal Acetate Combined With a Single or Repeated Levonorgestrel 1.5mg Oral Dose on Inhibition of Ovulation, Endometrial Changes and Bleeding Patterns in Normal Cycling Women
Brief Summary The purpose of this study is to determine the effect of a contraceptive vaginal ring on inhibition of ovulation, endometrial changes and bleeding patterns in normal cycling women.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovulation Inhibition
Intervention  ICMJE Drug: Ulipristal acetate
CVR delivering Ulipristal acetate and one tablet levonorgestrel.
Study Arms  ICMJE
  • Active Comparator: 1.5 mg tablet LNG after 12 weeks
    CVR delivering 2,500 µg of Ulipristal acetate per day and a single dose of levonorgestrel delivered in a 1.5 mg tablet after 12 weeks of CVR use
    Intervention: Drug: Ulipristal acetate
  • Active Comparator: 1.5 mg tablet LNG every 4 weeks
    CVR delivering 2,500 µg of Ulipristal acetate per day and one 1.5 mg tablet levonorgestrel every 4 weeks of CVR use (three times).
    Intervention: Drug: Ulipristal acetate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 11, 2017)
19
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2015)
20
Estimated Study Completion Date  ICMJE December 31, 2017
Estimated Primary Completion Date November 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Not at risk for pregnancy based on one of the following: a. subject has undergone sterilization; b. subject is monogamous and her male partner has undergone sterilization
  • Have regular menstrual cycles of 25-35 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
  • Women not living in the catchment area of the clinic
  • Known hypersensitivity to progestins or antiprogestins
  • Known hypersensitivity to silicone rubber
  • Any chronic disease
  • All contraindications to oral contraceptive use, including: a. Thrombophlebitis or thromboembolic disorders; b. Past history of deep vein thrombophlebitis or thromboembolic disorders; c. Past or current cerebrovascular or coronary artery disease; d. Migraine with focal aura; e. Known or suspected carcinoma of the breast; f. Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia; g. Undiagnosed abnormal genital bleeding; h. Cholestatic jaundice of pregnancy or jaundice with prior pill use; i. Hepatic adenomas or carcinomas; j. Known or suspected pregnancy
  • Desire to get pregnant during the study (through the use of reproductive technology for sterilized women or vasectomy reversal for sterilized partners)
  • 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 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)
  • Smoking in women who will be 35 years during the course of the trial; women < 35 years who smoke greater than 15 cigarettes per day must be evaluated by the PI for inclusion based on risk factors that would increase their risk for CVD and thromboembolism, e.g. lipid levels, glucose level, BP, BMI, family history of CVD at a young age.
  • Women with severe cystoceles or rectoceles
  • Use within the past 2 months of any implanted hormonal contraceptives including Mirena [progestin containing intrauterine system (IUS)] or Norplant (subdermal implant delivering LNG). 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 have been 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 during the control cycle of ≥10nmol/L will be excluded from further participation in the study (See Section 13.4.1)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Dominican Republic
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02451826
Other Study ID Numbers  ICMJE 674
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Population Council
Study Sponsor  ICMJE Population Council
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ruth Merkatz, Ph.D. Population Council
PRS Account Population Council
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP