As the trial is intended to investigate a new contraceptive medicinal product, the study subjects included are not characterized by a specific medical condition. MedDRA version: 8.1 Level: PT Classification code 10010808 Term: Contraception
Conditions
Interventions
Product Name: Nestorone®/Ethinyl Estradiol Contraceptive Vaginal Ring
Product Code: 150/15 NES/EE CVR
Pharmaceutical Form: Vaginal delivery system
INN or Proposed INN: ethinylestradiol
CAS Number: 57-
ST 1435
Other descriptive name: 16-methylene-17a-acetoxy-19-nor-pregn-4-ene-3,20 dione
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 103-
Sponsors
International Committee for Contraception Research of the Population Council
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Healthy women, aged 18-=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a. Known hypersensitivity to estrogens or progestins b. Known hypersensitivity to silicone rubber. c. Known or suspected pregnancy. d. History of infertility of >1.0 year in woman or her male partner. e. History of vasectomy or sterility in male partner; tubal ligation (sterilization) in women. f. Undiagnosed abnormal genital bleeding. g. Undiagnosed vaginal discharge or vaginal lesions or abnormalities. h. History of pelvic inflammatory disease since last pregnancy episode. i. History of toxic shock syndrome. j. In accordance with the Bethesda system of classification: Women with a current abnormal Pap 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. In accordance with other Pap class systems: · Women with high grade dysplasia are excluded. · Women with low grade dysplasia or CIN I interpretation on Pap smear may participate if further evaluated with colposcopy and, as needed, biopsy with endocervical curettage. · Women may participate if colposcopy findings are negative provided there is appropriate follow up in accordance with local standards of care; · Women whose colposcopy results indicate need for biopsy may participate as long as biopsy results indicate there is no lesion with a severity > CIN I and endocervical curettage results are negative. k. Cystoceles or rectoceles or other anatomical abnormality that would preclude use of a vaginal ring. l. Women planning to undergo major surgery. m. Smoking in women who are 35 years and over or will be 35 years during the course of the trial; women 85 mm Hg and/or systolic BP >135 mm Hg after 5-10 minutes rest. bb. Known or suspected alcoholism or drug abuse. cc. Abnormal serum chemistry values according to the physician’s judgment. dd.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate the cycle control, bleeding patterns, side effects, and acceptability of a 21-day continuous use regimen of the CVR, followed by one week off per cycle. ;Primary end point(s): The primary efficacy endpoint is the Pearl Index per 100 woman years for women <= 35 years. ;Main Objective: To evaluate one-year data on the contraceptive efficacy and safety of the 150/15 NES/EE CVR as the basis for regulatory approvals of this CVR as a new delivery system for contraception. | — |
Countries
Finland, Hungary, Sweden
Outcome results
None listed