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Postcoital Testing Study of the SILCS Diaphragm Used With 3% N-9 Gel, ContraGel, or No Gel

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ClinicalTrials.gov Identifier: NCT02309554
Recruitment Status : Completed
First Posted : December 5, 2014
Last Update Posted : August 1, 2016
Sponsor:
Information provided by (Responsible Party):
CONRAD

Brief Summary:
This post coital test study is a Phase I multi-center, randomized, crossover, non-significant risk device study to be carried out at two clinical sites/centers. The products to be tested are the SILCS diaphragm with 3% Nonoxynol-9 Gel (N-9) (spermicide), the SILCS diaphragm with ContraGel, and the SILCS diaphragm alone. Participants will be randomized to the order of product use, with a goal of 10 participants completing the study.

Condition or disease Intervention/treatment Phase
Contraception Other: SILCS diaphragm used with ContraGel Other: SILCS diaphragm used with 3% Nonoxynol-9 Other: SILCS diaphragm Phase 1

Detailed Description:

Each participant will be seen in approximately nine visits, over a period of 6-8 months, and will be contacted approximately 7 days after the final visit. Volunteers will be consented at Visit 1 and undergo procedures to confirm they are eligible to continue in the study.

Each participant will undergo four postcoital test (PCT) cycles:

  1. The first PCT cycle will be a baseline cycle, done without the use of any product, in order to demonstrate the participant's ability to undergo normal ovulatory events and to produce receptive, midcycle cervical mucus. The partner's ability to produce motile sperm capable of penetrating the cervical mucus is also evaluated in this cycle.
  2. Test PCT cycles will be carried out during the subsequent menstrual cycles using either the SILCS diaphragm with 3% N-9, the SILCS diaphragm with ContraGel, or the SILCS diaphragm alone following a sequence of randomized treatment. Cycles may need to be repeated depending on the characteristics of the cervical mucus and the number of sperm found in the vaginal pool and endocervical specimens.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase I Postcoital Testing Study of the SILCS Diaphragm Used With 3% Nonoxynol-9 Gel, ContraGel, or No Gel
Study Start Date : December 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Active Comparator: SILCS Diaphragm alone
Participants will complete a post-coital test cycle with SILCS diaphragm alone.
Other: SILCS diaphragm
SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring

Active Comparator: SILCS Diaphragm with 3% Nonoxynol-9 Gel
Participants will complete a post-coital test cycle with SILCS diaphragm used with 3% nonoxynol-9 gel.
Other: SILCS diaphragm used with 3% Nonoxynol-9
SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring. 3% Nonoxynol-9 (branded as Gynol II) is clear, unscented water soluble greaseless gel packed in plastic tubes with a vaginal applicator.

Other: SILCS diaphragm
SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring

Experimental: SILCS Diarphragm with ContraGel
Participants will complete a post-coital test cycle with SILCS diaphragm used with ContraGel.
Other: SILCS diaphragm used with ContraGel
SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring. ContraGel is a clear, water soluble greaseless gel packed in a metal tube.

Other: SILCS diaphragm
SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring




Primary Outcome Measures :
  1. Proportion of women with an average of fewer than 5 progressively motile sperm per high powered field (HPF) as a measure of preliminary effectiveness [ Time Frame: 2-3 hours following coitus ]
    Fewer than 5% progressively motile sperm per high power field is considered indicative of acceptable barrier function. Will be calculated separately for each test cycle.

  2. Per-women average number (across 9 HPFs) of progressively motile sperm per HPF as a measure of preliminary effectiveness. [ Time Frame: 2-3 hours following coitus ]
    Mean, median, standard deviation and IQR will be assessed for the baseline cycle and during each test PCT, across all women. Qualitative assessments of change from baseline, if any, will be based on medians and IQRs.


Secondary Outcome Measures :
  1. Number of treatment emergent adverse experiences among female participants as a measure of safety [ Time Frame: Beginning at Visit 2 through 7-10 days after the final study visit; an average of 6-8 months ]
    Urogenital, product-related, and/or serious AEs will be assessed

  2. Number of treatment emergent adverse experiences among male partners as a measure of safety [ Time Frame: Beginning at Visit 2 through 7-10 days after the final study visit; an average of 6-8 months ]
    Urogenital, product-related, and/or serious AEs will be assessed



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18-45 years, inclusive
  2. General good health, by volunteer history and per investigator judgment
  3. History of regular menstrual cycles of 24-35 days (inclusive), by volunteer report
  4. History of Pap smears and follow-up consistent with standard medical practice as outlined in the Study Manual or willing to undergo a Pap smear at Visit 1
  5. Willing to abstain from intercourse and use of vaginal products as required in the protocol
  6. Willing to use non-spermicidal, lubricated condoms from the first day of each menstrual cycle until 72 hours before expected midcycle
  7. In a mutually monogamous relationship for at least the last four months with a male partner who: 7a. Is at least 18 years old; 7b. Has no known risk for STIs; 7c. Is willing and able to comply with protocol requirements including sexual activity/ abstinence and condom use requirements; and 7d. Can engage in vaginal intercourse with the participant, with and without condoms, as specified in protocol
  8. Protected from pregnancy by female tubal sterilization
  9. Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to easy genital tract sample collection
  10. Willing to give voluntary consent, sign an informed consent form and comply with study procedures as required by the protocol

Exclusion Criteria:

  1. History of hysterectomy
  2. Vasectomy in male partner
  3. Sterility or known history of sperm dysfunction in male partner
  4. Currently pregnant or within two calendar months from the last pregnancy outcome. Note: If recently pregnant must have had at least two spontaneous menses since pregnancy outcome
  5. Current use of any hormonal contraceptive or a copper IUD, or use of Depo-Provera in the last 120 days
  6. Currently breastfeeding or having breastfed an infant in the last two months, or planning to breastfeed during the course of the study
  7. Significant gynecological abnormalities (including abnormal vaginal bleeding or excessive vaginal discharge)
  8. Device does not appropriately fit volunteer, as determined by clinician
  9. Inability to insert, position, and/or remove study device, by clinician or volunteer
  10. History of sensitivity/allergy to 3% N-9, latex, ingredients in ContraGel, or silicone, for either the volunteer or her male partner
  11. In the last six months, either the volunteer or her male partner diagnosed with or treated for any STI or pelvic inflammatory disease. Note: Women with a history of genital herpes or condylomata who have been asymptomatic for at least six months may be considered for eligibility
  12. Positive test for Trichomonas vaginalis, Neisseria gonorrhea or Chlamydia trachomatis
  13. Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or vesicles suspicious for a sexually transmitted infection
  14. Positive test for HIV
  15. Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting, etc.)
  16. Known current drug or alcohol abuse which could impact study compliance
  17. Participation in any other investigational trial within the last 30 days or planned participation in any other investigational trial during the study
  18. History of gynecological procedures (including genital piercing) on the external genitalia, vagina or cervix within the last 14 days
  19. Abnormal finding on laboratory or physical examination or a social or medical condition in either the volunteer or her male partner which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309554


Locations
United States, Virginia
Clinical Research Center, Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
Dominican Republic
ProFamilia
Santo Domingo, Dominican Republic
Sponsors and Collaborators
CONRAD

Responsible Party: CONRAD
ClinicalTrials.gov Identifier: NCT02309554     History of Changes
Other Study ID Numbers: A13-126
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: August 1, 2016
Last Verified: July 2016

Keywords provided by CONRAD:
Contraception
Post coital test
Vaginal
Diaphragm

Additional relevant MeSH terms:
Nonoxynol
Spermatocidal Agents
Antispermatogenic Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Male