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

Completed · Phase 2

Conditions studied: Suppression of Ovulation

In brief

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.

Key facts

Study ID: NCT01586000
Run by: Kimberly Myer
People needed: 197
Starts: 2012-03-01
Expected to finish: 2015-05-01
Last updated by the study team: 2025-12-08

Who can join

Age: 18 and older, up to 39. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Women who meet all the following criteria are eligible for enrollment in the trial:
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.

You may not qualify if…

Women who meet any of the following criteria are not eligible for enrollment in the trial:
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:
Thrombophlebitis or thromboembolic disorders.
Past personal history of deep vein thrombophlebitis or thromboembolic disorders.
History of venous thrombosis or embolism in a first-degree relative <55 years of age suggesting familial defect in blood coagulation system, which in the opinion of the investigator, suggests use of a hormonal contraceptive could pose a significant risk.
History of stroke.
Known or suspected carcinoma of the breast.
Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.
Undiagnosed abnormal genital bleeding.
Cholestatic jaundice of pregnancy or jaundice with prior oral contraceptive use.
Hepatic adenomas or carcinomas.
Known or suspected pregnancy.
Smoking in women who are 35 years and over or will be 35 years during the course of the trial; women <35 years who smoke 15 cigarettes or more per day must be evaluated by the investigator for inclusion based on risk factors that would increase their risk for cardiovascular disease (CVD) and thromboembolism, e.g. lipid levels, glucose level, BP, BMI, family history of CVD at a young age.
History of retinal vascular lesions, unexplained partial or complete loss of vision.
Headaches with focal neurological symptoms (e.g., migraines with auras).
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 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):
In accordance with the Bethesda system of classification: smear suggestive of high-grade pre-cancerous lesion(s), including high grade squamous intraepithelial lesions (HGSILs), are excluded;
Women with low grade squamous intraepithelial lesion (LGSIL) or atypical squamous cells of undetermined significance (ASCUS)/high-risk human papillomavirus (HPV) positive, or Atypical squamous cells, cannot rule out a high grade lesion (ASC-H) may participate if further evaluated with colposcopy and biopsy determines no evidence of a lesion with a severity greater than cervical intraepithelial neoplasia (CIN) I.
Women with a biopsy finding of CIN I should have follow-up for this finding per standard of care; women are excluded if treatment is indicated.

Where it is running

Johns Hopkins School of Medicine — Baltimore, Maryland, United States
NYU School of Medicine — New York, New York, United States
Columbia University — New York, New York, United States
University of Cincinnati — Cincinnati, Ohio, United States
Oregon Health & Science University — Portland, Oregon, United States
University of Pennsylvania School of Medicine — Philadelphia, Pennsylvania, United States
Univeristy of Pittsburgh School of Medicine — Pittsburgh, Pennsylvania, United States
Eastern Virginia Medical School — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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