Study of the Safety, Efficacy and Cycle Control of a Contraceptive Vaginal Ring

Study Description

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Brief Summary:

The purpose of this study is to evaluate the 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.

Condition or disease	Intervention/treatment	Phase
Contraception	Drug: 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR)	Phase 3

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1143 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	A Multicenter, Open-label Study on the Efficacy, Cycle Control and Safety of a Contraceptive Vaginal Ring Delivering a Daily Dose of 150µg of Nestorone® and 15µg of Ethinyl Estradiol (150/15 NES/EE CVR)
Study Start Date :	December 2006
Actual Primary Completion Date :	January 2009
Actual Study Completion Date :	September 2009

Arms and Interventions

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Arm	Intervention/treatment
Subsample; Thirty-nine women already enrolled at three centers for a Nested Phase 3 pharmacokinetic study will be counted in the 300B Phase 3 study.	Drug: 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR); 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.

Outcome Measures

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Primary Outcome Measures :

1. 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. [ Time Frame: 12 Months ]

Secondary Outcome Measures :

1. To evaluate the cycle control, bleeding patterns and side effects [ Time Frame: 12 Months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 39 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Healthy women, aged 18-<40 years who wish to use a combined hormonal contraceptive.
• Women not intending to become pregnant for 13 months.
• Intact uterus and both ovaries.
• 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.
• Sexually active (currently) and willing to discontinue current contraceptive method to participate in the study.
• In the opinion of the investigator, able to comply with the protocol, e.g. live within the study site catchment area or within a reasonable distance from the site.
• Do not meet any of the exclusion criteria.
• Signed informed consent prior to entry into the trial.

Exclusion Criteria:

• Known hypersensitivity to estrogens or progestins.
• Known hypersensitivity to silicone rubber.
• Known or suspected pregnancy.
• History of infertility of >1.0 year in woman or her male partner.
• History of vasectomy or sterility in male partner; tubal ligation (sterilization) in women
• Undiagnosed abnormal genital bleeding.
• Undiagnosed vaginal discharge or vaginal lesions or abnormalities. (Subjects diagnosed at screening with Chlamydia or gonorrhea may be included in the trial following treatment; partner treatment is also recommended. 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.)
• History of pelvic inflammatory disease since last pregnancy episode.
• History of toxic shock syndrome.
• Current abnormal Pap smear (women who have abnormal Paps but are ASCUS HPV negative may participate provided there is follow up for this finding per standard of care).
• Cystoceles or rectoceles or other anatomical abnormality that would preclude use of a vaginal ring.
• Women planning to undergo major surgery.
• 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 must be evaluated by the PI for inclusion based on risk factors that would increase their risk for CVD, e.g. lipid levels, glucose level, BP, BMI, family history of CVD at a young age.
• Breastfeeding.
• Current or past 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 principal investigator, suggests use of a hormonal contraceptive could pose a significant risk.
• Cerebrovascular or cardiovascular disease.
• History of retinal vascular lesions, unexplained partial or complete loss of vision.
• Known or suspected carcinoma of the breast.
• Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.
• Past history of any other carcinoma unless in remission for more than 5 years.
• Current or past medically diagnosed severe depression, which, in the opinion of the investigator, could be exacerbated by use of a hormonal contraceptive.
• Headaches with focal neurological symptoms.
• Severe constipation.
• History of cholestatic jaundice of pregnancy or jaundice with prior steroid use.
• Benign or malignant liver tumors; active liver disease.
• Diastolic blood pressure (BP) ³85 mm Hg and/or systolic BP ³135 mm Hg after 5-10 minutes rest.
• Known or suspected alcoholism or drug abuse.
• Abnormal serum chemistry values according to the physician's judgment.
• Participation in another clinical trial within last 30 days.
• Weight >95 kg or >209 lbs.
• Use of liver enzyme inducers on a regular basis.
• Use of monthly injectable contraceptives (e.g. cyclofem) unless suspended 2 months before initiation of treatment. Use of Depo-Proveraâ [depo-medroxyprogesterone (DMPA)] unless suspended 6 months before treatment.
• Current use of implanted hormonal contraceptives, including Mirenaâ [progestin containing intrauterine system (IUS)], Jadelleâ, Norplantâ or Implanonâ (subjects using any of these methods who request removal for reasons unrelated to the purpose of enrollment in this study may be considered for participation).
• Current use of a non-hormonal IUD. Subjects with IUDs who request removal for reasons unrelated to the purpose of enrollment in this study may be considered for participation.
• Known HIV infection.
• Women at high risk of contracting HIV, e.g. women with multiple sex partners who need to use condoms consistently, injection drug users. If women enrolled in the study do use condoms to protect against STIs, they should be instructed that this occasional use should be with non-N-9 containing condoms and they should record condom use in their diaries. Women found to have an STI at screening will be treated prior to inclusion in the study (with the exception of those infected with HIV).

Contacts and Locations

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Locations

United States, California
California Family Health Council
Los Angeles, California, United States, 90010
United States, Colorado
University of Colorado - Adv. Repro. Med.
Denver, Colorado, United States, 80010
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536-0293
United States, Maryland
Contraceptive Research and Programs
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
United States, New York
NYU Medical Center Family Planning Division
New York, New York, United States, 10016
Columbia University
New York, New York, United States, 10032
United States, Ohio
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45267
MacDonald Physicians, Inc.
Cleveland, Ohio, United States, 44124
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97201
United States, Pennsylvania
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
UT Southwestern Medical Center; Division of Community Women's Health Care
Dallas, Texas, United States, 75235
United States, Virginia
Jones Institute of Repro Medicine, EVMS
Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Population Council

Investigators

Study Director:	Diana L. Blithe, PH.D.	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Huang Y, Merkatz RB, Hillier SL, Roberts K, Blithe DL, Sitruk-Ware R, Creinin MD. Effects of a One Year Reusable Contraceptive Vaginal Ring on Vaginal Microflora and the Risk of Vaginal Infection: An Open-Label Prospective Evaluation. PLoS One. 2015 Aug 12;10(8):e0134460. doi: 10.1371/journal.pone.0134460. eCollection 2015.

Responsible Party:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00455156 History of Changes
Other Study ID Numbers:	HHSN275200403366I; CCN006
First Posted:	April 3, 2007
Last Update Posted:	October 29, 2012
Last Verified:	April 2012

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Contraception; Vaginal Ring

Additional relevant MeSH terms:

Estradiol; Polyestradiol phosphate; Ethinyl Estradiol; Estradiol 3-benzoate; Estradiol 17 beta-cypionate; Estradiol valerate; Contraceptive Agents	ST 1435; Estrogens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents, Female