NCT00578877

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2007

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
7.8 years until next milestone

Results Posted

Study results publicly available

August 24, 2017

Completed
Last Updated

March 16, 2018

Status Verified

August 1, 2017

Enrollment Period

1.8 years

First QC Date

December 19, 2007

Results QC Date

January 7, 2016

Last Update Submit

February 16, 2018

Conditions

Contraception

Keywords

ContraceptionSILCS DiaphragmContraceptive Gel

Outcome Measures

Primary Outcomes (1)

  • Percent Probability of Pregnancy Among Users of the SILCS Diaphragm Used With Contraceptive Gel Over 6 Months of Typical Use

    6 months

Secondary Outcomes (1)

  • Percent Women With Urogenital Adverse Events.

    6 months

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Gynol II (2% N-9 gel)

Device: SILCS DiaphragmCombination Product: Nonoxynol-9 Gel

Arm 2

EXPERIMENTAL

Buffer Gel

Device: SILCS DiaphragmCombination Product: Buffer Gel

Interventions

SILCS DiaphragmDEVICE

SILCS Diaphragm used with 5 ml gel

Arm 1Arm 2
Nonoxynol-9 GelCOMBINATION_PRODUCT

Gynol II (2% N-9 gel)

Arm 1
Buffer GelCOMBINATION_PRODUCT

Buffer Gel

Arm 2

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • In order to enroll into the clinical trial, potential subjects must:
  • be healthy sexually active women, at risk for pregnancy and desiring contraception;
  • be within the age range of 18 through 40 years, inclusive;
  • be at low-risk for HIV or STI infection, currently have (at least 4 months) a single sexual partner who is also at low-risk for HIV or STI infection, and expect the same partner for the study;
  • have a negative urine pregnancy test ;
  • have normal menstrual cycles with a usual length of 24 to 35 days over the last 2 months ;
  • have a documented history of at least 6 weeks and two spontaneous, normal menstrual cycles since last pregnancy outcome, one spontaneous normal menstrual cycle after discontinuing hormonal contraception or therapy and 10 months since last DepoProvera injection;
  • not be actively desiring pregnancy for approximately 7 months and willing to accept an unknown risk of pregnancy;
  • be willing to engage in at least 4 acts of heterosexual vaginal intercourse per cycle ;
  • be willing to be fitted with a standard diaphragm and use the SILCS diaphragm with assigned study gel during the study;
  • be willing to only use the assigned study gel with the SILCS diaphragm as the sole method of contraception over the course of the study;
  • agree not to participate in any other clinical trials during the course of the study;
  • be willing and able to comply with study procedures and to return to the clinic for scheduled follow-up visits; and
  • colposcopy and microflora substudy only:
  • be willing to avoid using tampons for 72 hours prior to clinic visits or any intravaginal product other than those provided by the investigator for the duration of participation; and
  • +11 more criteria

You may not qualify if:

  • In order to enroll into the clinical trial, potential subjects must not:
  • have an allergy to silicone, nylon, latex or dry natural rubber products, and/or spermicides or products containing N-9;
  • have a history of toxic shock syndrome (TSS);
  • have a suspected or diagnosed UTI or vaginitis, unless treated and symptoms resolved prior to enrollment;
  • have a history suggestive of infertility, defined as any of the following:
  • known history of a fertility problem, sterilization, ectopic pregnancy, hospitalization for pelvic inflammatory disease (PID), or endometriosis unless participant has had a subsequent spontaneous intrauterine pregnancy; or
  • abnormalities on pelvic examination at enrollment that may impair fertility;
  • have contraindications to pregnancy (medical condition) or chronic use of class D or X medications;
  • have high risk for HIV or other sexually transmitted infections (STIs):
  • have had more than one sexual partner in the past four months;
  • have shared injection drug needles within the past six months;
  • have, or suspected to have, HIV infection; or
  • have been diagnosed or treated for any STI, including Trichomonas vaginalis, (with the exception of recurrent genital herpes or condylomata) or PID within the past six months prior to the enrollment visit;
  • have signs or symptoms of current cervicitis, endometritis or PID or have clinical evidence of HSV on exam;
  • be lactating or breastfeeding;
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

California Family Health Council, Inc

Los Angeles, California, 90010, United States

Location

John Hopkins Community Physicians

Baltimore, Maryland, 10195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213-3180, United States

Location

Advances in Health, Inc.

Houston, Texas, 77030, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

  • Schwartz JL, Weiner DH, Lai JJ, Frezieres RG, Creinin MD, Archer DF, Bradley L, Barnhart KT, Poindexter A, Kilbourne-Brook M, Callahan MM, Mauck CK. Contraceptive efficacy, safety, fit, and acceptability of a single-size diaphragm developed with end-user input. Obstet Gynecol. 2015 Apr;125(4):895-903. doi: 10.1097/AOG.0000000000000721.

    PMID: 25751199DERIVED

Results Point of Contact

Title
Jill Schwartz, M.D.
Organization
CONRAD
jschwartz@conrad.org
703-276-3913

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 21, 2007

Study Start

January 1, 2008

Primary Completion

October 1, 2009

Study Completion

November 1, 2009

Last Updated

March 16, 2018

Results First Posted

August 24, 2017

Record last verified: 2017-08

Locations

US(6)