Postcoital Testing of the SILCS Diaphragm

December 19, 2007 updated by: CONRAD

A Phase I Postcoital Testing and Safety Study of the SILCS Diaphragm, Prototype VI

This was a Phase I multi-center, randomized study in 40 healthy, sexually active women not at risk for pregnancy due to previous female sterilization. The male partners of the participants were consented to participate in the study. The clinician evaluating the cervical mucus for midcycle characteristics and presence of sperm was blinded as to gel used. The product tested was the SILCS diaphragm with Gynol II (spermicide) and the SILCS diaphragm with KY Jelly (lubricant). The sequence of diaphragm and gel use was determined by randomization. The study was conducted at two centers, Magee-Womens Hospital in Pittsburgh, Pennsylvania and CONRAD's Clinical Research Center at the Eastern Virginia Medical School in Norfolk, Virginia.

The study consisted of a screening visit, a baseline cycle, and up to 2 cycles of post-coital tests (PCTs) for a total of 7 visits. The first PCT was a baseline PCT, performed without the use of any product, in order to demonstrate the subject's ability to produce receptive, midcycle cervical mucus. The partner's ability to produce motile sperm capable of penetrating the cervical mucus was evaluated in this cycle. Test PCTs were carried out during the second and third menstrual cycle using either the SILCS diaphragm with N-9 or the SILCS diaphragm with lubricant. Cycles were repeated depending on the characteristics of the cervical mucus and the number of sperm found in the vaginal pool and endocervical specimens; thus, some women may undergo more than three PCTs. An additional test cycle with a modified polymer spring device was performed in a subset of participants.

Colposcopy was performed during the mucus check and post-coital test visits in all three cycles in order to document the baseline condition of the vagina and cervix pre- and post-intercourse and, in test cycles, to note the effect of product.

Vaginal samples were taken from the posterior fornix of the vagina and the cervical os at each visit during the baseline and test cycles to measure for the presence of PSA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Eastern Virginia Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Female Participants

    • 18-45 years old (inclusive)
    • In good general health based on medical history & physical exam
    • Previous bilateral tubal ligation or salpingectomy
    • Regular menstrual cycles of 24-35 days (inclusive)
    • Negative urine pregnancy test at admission
    • Not currently breast feeding
    • No significant gynecological abnormalities
    • Normal cervical Papanicolaou smear within 6 months preceding enrollment
    • In a stable relationship with only one sexual partner
    • Willing to undergo at least three PCTs
    • Willing to abstain from intercourse and use of vaginal products
    • Willing to use condoms from day 1 of each menstrual cycle until midcycle

  2. Male Participants

    • Age 18 years and older
    • Able and willing to provide written informed consent
    • Willing to engage in intercourse with and without condoms

Exclusion Criteria:

  1. Female Participants

    • History in subject of allergy to study products
    • Positive wet mount for Trichomonas vaginalis
    • History of any STD within 6 months of enrollment
    • Device does not appropriately fit volunteer, as determined by clinician
    • Inability to insert, position, and/or remove study device
    • Participation in another study within 30 days prior to enrollment

  2. Male Participants

    • History of allergy to study products
    • History of vasectomy
    • In the six months prior to study, diagnosed with or treated for any STI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
SILCS with K-Y Jelly
Other: SILCS and lubricant
Active Comparator: 2
SILCS with N-9
Other: SILCS and spermicide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of women with any sperm in the cervical mucus, with ≥ 5 progressively motile sperm per high power field (HPF), and the average number of progressively motile sperm per HPF.
Time Frame: Within 2-3 hours of intercourse.
Within 2-3 hours of intercourse.

Secondary Outcome Measures

Outcome Measure
Time Frame
Symptoms and signs of irritation of the external genitalia, cervix, and vagina before and after intercourse and by gel product. The handling, fit, and general acceptability of the SILCS diaphragm was assessed.
Time Frame: Before and after intercourse
Before and after intercourse

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CONRAD

Investigators

  • Study Director: Jill Schwartz, MD, CONRAD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

November 19, 2007

First Submitted That Met QC Criteria

November 19, 2007

First Posted (Estimate)

November 21, 2007

Study Record Updates

Last Update Posted (Estimate)

December 24, 2007

Last Update Submitted That Met QC Criteria

December 19, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A02-081

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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