A multicenter, open-label study on the efficacy, cycle control and safety of a contraceptivevaginal ring delivering a daily dose of 150 µg of Nestorone(R) and 15 µg of ethinyl estradiol (150/15 NES/EE CVR)

International Committee for Contraception Research of the Population Council0 sites2,200 target enrollmentJuly 27, 2006

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: As the trial is intended to investigate a new contraceptive medicinal product, the study subjects included are not characterized by a specific medical condition.
Sponsor: International Committee for Contraception Research of the Population Council
Enrollment: 2200
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

July 27, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

International Committee for Contraception Research of the Population Council

•a. Healthy women, aged 18\-\<40 years who wish to use a combined hormonal contraceptive.
•b. Women not intending to become pregnant for 13 months.
•c. Intact uterus and both ovaries.
•d. Prior history of regular menstrual cycles of 28 ± 7 days when not using hormonal contraception; if postpartum or postabortal, history of regular menstrual cycles of 21\-35 days in length and at least one cycle (2 menses) with a cycle length consistent with her past cycles.
•e. Sexually active (currently) and willing to discontinue current contraceptive method to participate in the study.
•f. In the opinion of the investigator, able to comply with the protocol, e.g. live within the clinic catchment area or within a reasonable distance from the clinic.
•g. Do not meet any of the exclusion criteria.
•h. Signed informed consent prior to entry into the trial.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•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.
•f. Undiagnosed abnormal genital bleeding.
•g. Undiagnosed vaginal discharge or vaginal lesions or abnormalities. (Subjects diagnosed at screening with a chlamydia or gonococcus infection may be included in the trial following treatment; partner treatment is also recommended. Subjects at high risk for reinfection can be included or excluded per investigator’s discretion.)
•h. History of pelvic inflammatory disease since last pregnancy episode.
•i. History of toxic shock syndrome.
•j. Current abnormal Pap smear (women who have abnormal Pap smears but are ASCUS HPV negative may participate provided there is follow\-up for this finding per standard of care).