A Dose-finding Study to Evaluate the Effect of a Contraceptive Vaginal Ring, Releasing Nestorone®… (NCT01586000) | Clinical Trial Compass
CompletedPhase 2
A Dose-finding Study to Evaluate the Effect of a Contraceptive Vaginal Ring, Releasing Nestorone® and Estradiol, on Cycle Control, Ovulation Inhibition, and Pharmacokinetics in Normal Cycling Women
United States197 participantsStarted 2012-03
Plain-language summary
This clinical trial is an experimental research study using a potential new form of birth control. Clinical trials include people who volunteer to take part in a study. Take your time to decide if you want to be part of this experimental research study. If you want to know more about this study first, ask the study doctor or study site staff. The investigators can also give you the study information written for doctors and clinic staff.
Who can participate
Age range18 Years – 39 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Healthy women of reproductive age (18-39 years, inclusive, at the enrollment visit).
✓. Have a regular menstrual cycle that is 21-35 days in duration.
✓. Have intact uterus and both ovaries.
✓. Will be able and willing to comply with the protocol and sign an informed consent.
✓. Will not be at risk for pregnancy. They will be consistently using a non-hormonal method, have a surgically sterile male partner with a vasectomy, be abstinent, or be in a same-sex relationship from the control period through study exit (including recovery period).
✓. Will have diastolic blood pressure (BP) ≤85 mm Hg and systolic BP ≤135 mm Hg after 5 minutes in sitting position.
✓. Willing to abstain from use of non-water based vaginal lubricant during the study.
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 clinic.
✕. Known hypersensitivity to progestins or estrogen.
✕. All contraindications to combined estrogen-progestin contraceptive use including:
✕. 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 vaginitis (yeast, trichomonas, or bacterial vaginitis) 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 clinically significant Pap test abnormality, as managed by current local or national guidelines. Women with a current abnormal Pap (within the last nine months):