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

NCT02451826 | Unknown Phase 1

• 1 other identifier: 674
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovulation Inhibition

Keywords

ovulation inhibition; endometrial changes; bleeding patterns

Outcome Measures

Primary Outcomes (1)

• Pharmacodynamic efficacy as measured by the effects of a vaginal ring delivering Ulipristal acetate consistently combined with levonorgestrel administration on the endometrium

  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).

  3 months

Secondary Outcomes (1)

• Safety as measured by number of participants with occurrence of adverse events (AEs) and concomitant medication use

  3 months

Study Arms (2)

1.5 mg tablet LNG after 12 weeks

ACTIVE COMPARATOR

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

Drug: Ulipristal acetate

1.5 mg tablet LNG every 4 weeks

ACTIVE COMPARATOR

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).

Drug: Ulipristal acetate

Interventions

Ulipristal acetate DRUG

CVR delivering Ulipristal acetate and one tablet levonorgestrel.

1.5 mg tablet LNG after 12 weeks; 1.5 mg tablet LNG every 4 weeks

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Population Council: lead

Study Sites (1)

Profamilia

Santo Domingo, Dominican Republic

Location

MeSH Terms

Interventions

ulipristal acetate

Study Officials

• Ruth Merkatz, Ph.D.

  Population Council

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: May 22, 2015
• Study Start: May 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: December 31, 2017
• Last Updated: August 15, 2017

Record last verified: 2017-08

Locations

DO (1)