Dose Finding Study of Contraceptive Vaginal Ring With Different Estradiol Levels in Combination W… (NCT02626208) | Clinical Trial Compass
CompletedPhase 2
Dose Finding Study of Contraceptive Vaginal Ring With Different Estradiol Levels in Combination With Nestorone
United States65 participantsStarted 2016-01
Plain-language summary
This clinical trial investigates a new vaginal delivery system made of silicone rubber, containing Nestorone®, a 19-nor progesterone derivative and a low dose of serum estradiol (E2). The investigators plan to evaluate one-month data on the serum estradiol (E2) levels of three different contraceptive vaginal rings that contain a fixed dose of NES and escalating doses (75 µg/day, 100 µg/day, or 200 µg/day) of estradiol as the basis for selecting a CVR for a larger contraceptive efficacy trial.
Who can participate
Age range18 Years – 39 Years
SexFEMALE
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Inclusion criteria
✓. Good general overall health with no chronic medical conditions that result in periodic exacerbations that require significant medical care.
✓. Age 18-39 years, inclusive, at the enrollment visit.
✓. Have a regular menstrual cycle 21-35 days in duration when not using hormonal contraception
✓. Have an intact uterus and both ovaries.
✓. Able and willing to comply with the protocol and sign an informed consent.
✓. Consistent use of effective contraception during the preceding cycle (note: women who use oral, transdermal, vaginal, implantable or intrauterine hormonal contraceptives in the preceding cycle must have discontinued at least 7 days prior to start of treatment and not had unprotected intercourse since discontinuing the method).
✓. Not at high risk for pregnancy, defined as consistently using a non-hormonal method of contraception (including Copper IUDs); have a surgically sterile male partner with a vasectomy; be abstinent; or be in a same-sex relationship from the start of treatment through study exit (including recovery period).
✓. Have a negative pregnancy test at the admission visit.
Exclusion criteria
✕. Participating in another clinical trial involving an investigational product within the last 30 days (prior to screening) or planning to participate in another clinical trial during this study.
✕. Not living in the catchment area of the study site.
What they're measuring
1
Change in serum estradiol (E2) levels of three different contraceptive vaginal rings
Timeframe: Assessments will be taken before insertion of the study ring (Day 1); Day 4 or ; Twice weekly during study ring use (approximately Days 7 or 8, 11 or 12, 14 or 15, 18 or 19, 21 or 22, 25 or 26) and at removal of study ring (Day 28-30)
✕. Known hypersensitivity to progestins or estrogen.
✕. Contraindications to combined estrogen-progestin contraceptive use including:
✕. Desire to become pregnant during the study.
✕. Breastfeeding.
✕. 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 with vaginal infection (yeast, trichomonis, or bacterial vaginosis) may be enrolled after treatment. Investigators should make a determination if subjects are at high risk for reinfection, e.g. multiple sex partners, untreated partner, and whether such subjects can be included. In accordance with PI/medical designee assessment and local standards of practice, women with a history of genital herpes can be included if outbreaks are infrequent.
✕. A known clinically significant Pap test abnormality, as managed by current local or national guidelines that will require treatment during study participation.