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Sponsors and Collaborators: |
CONRAD United States Agency for International Development (USAID) Family Health International ReProtect Inc |
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Information provided by: | CONRAD |
ClinicalTrials.gov Identifier: | NCT00578877 |
This multi-center contraceptive effectiveness and safety study of the SILCS diaphragm will enroll approximately 450 couples at risk for pregnancy at six study sites in the U.S. The study will randomly assign approximately 300 couples to use the SILCS diaphragm with BufferGel and approximately 150 couples to use the SILCS diaphragm with Gynol II (2% N-9 gel). At two sites, a substudy involving colposcopy and microflora will be conducted in about 80 women (40 at each site). The primary objective of this study is to estimate the cumulative 6-month typical-use pregnancy probability for women using the SILCS diaphragm with a contraceptive gel.
Condition | Intervention | Phase |
---|---|---|
Contraception |
Device: SILCS Diaphragm |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Contraceptive Effectiveness and Safety Study of the SILCS Diaphragm: the Pivotal Study |
Estimated Enrollment: | 450 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
N-9 gel
|
Device: SILCS Diaphragm
used with 5 ml gel
|
2: Experimental
Buffer Gel
|
Device: SILCS Diaphragm
used with 5 ml gel
|
This multi-center contraceptive effectiveness and safety study of the SILCS diaphragm will enroll approximately 450 couples at risk for pregnancy w at six study sites in the U.S. The study will randomly assign approximately 300 couples to use the SILCS diaphragm with BufferGel (BG) and approximately 150 couples to use the SILCS diaphragm with Gynol II (2% N-9 gel). At two sites, a substudy involving colposcopy and microflora will be conducted in about 80 women (40 at each site). For certain evaluations, the data from a contraceptive study conducted by NICHD of the Ortho All-Flex diaphragm used with either BG or N-9 will be used as historical controls.
In the current study, each participant will agree to use the SILCS diaphragm with her assigned contraceptive gel as her only method of contraception for approximately 7 months (at least 190 days) and at least 6 menstrual cycles. Emergency contraception will be offered if unprotected intercourse occurs, according to local prescribing practices.
Each female participant will undergo four scheduled visits: Enrollment, After Cycle 1, After Cycle 3, and Final visits. Two weeks after enrollment, each participant will be called to determine if she has had any problems with the method and to assess compliance.
Recruitment for this study is expected to take about 12 months. Each subject's participation will last about 6-7 months. Site closeout is expected to take three months. The clinical portion of the study should last about 21 months. Data closure and analysis are expected to take three months and the Final Report two additional months.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Female Inclusion Criteria
In order to enroll into the clinical trial, potential subjects must:
colposcopy and microflora substudy only:
The male partner must be at least 18 years old and must not:
have known risks for STIs including HIV:
Female Exclusion Criteria
In order to enroll into the clinical trial, potential subjects must not:
have a history suggestive of infertility, defined as any of the following:
have high risk for HIV or other sexually transmitted infections (STIs):
have an abnormal Pap smear in the past 12 months defined as:
Contact: Jill L Schwartz, MD | 703 524-4744 | jschwartz@conrad.org |
Contact: Marianne M Callahan | 703 524-4744 | mcallahan@conrad.org |
United States, California | |
California family Health Council, Inc. | Recruiting |
Los Angeles, California, United States, 90010 | |
Contact: Karen Peacock 213-386-5614 ext 4599 peacockk@cfhc.org | |
Principal Investigator: Ron Frezieres, MSPH | |
United States, Maryland | |
John Hopkins Community Physicians | Recruiting |
Baltimore, Maryland, United States, 10195 | |
Contact: Kathy Brugh 410-338-3060 lbradle@jhmi.edu | |
Principal Investigator: Lynn Bradley, M.Sc | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213-3180 | |
Contact: Lynn Reid, PA-C 412-641-5496 lreid@mail.magee.edu | |
Principal Investigator: Mitch D Creinin, MD | |
University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Bhavisha Dhillon, RN 215-615-4204 DhillonB@obgyn.upenn.edu | |
Principal Investigator: Kurt Barnhart, MD | |
United States, Texas | |
Advances in Health, Inc. | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Robin Alanziz 713-798-7567 Adv_hlth@swbell.net | |
Principal Investigator: Alfred Poindexter, MD | |
United States, Virginia | |
Eastern Virginia Medical School | Recruiting |
Norfolk, Virginia, United States, 23507 | |
Contact: Bela Oza 757-446-8925 OzaBH@evms.edu | |
Principal Investigator: David Archer, MD |
Principal Investigator: | Ron Frezieres, MSPH | Californial Family Health Council, Inc |
Principal Investigator: | Mitch M Creinin, MD | University of Pittsburgh |
Principal Investigator: | Lynn Bradley, M.Sc. | John Hopkins Community Physicians |
Principal Investigator: | David Archer, MD | Eastern Virginia Medical School |
Principal Investigator: | Alfred Poindexter, MD | Advances in Health, Inc. |
Principal Investigator: | Kurt Barnhart, MD | University of Pennsylvania |
Responsible Party: | CONRAD ( Jill Schwartz, MD/Project Leader ) |
Study ID Numbers: | CONRAD C05-103 |
Study First Received: | December 19, 2007 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00578877 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Contraception SILCS Diaphragm Contraceptive Gel |