ContraceptionPhase 1NCT02309554
Postcoital Testing Study of the SILCS Diaphragm Used With 3% N-9 Gel, ContraGel, or No Gel
A Phase 1 study testing SILCS diaphragm used with ContraGel, SILCS diaphragm used with 3% Nonoxynol-9 and SILCS diaphragm in people with Contraception, run by CONRAD at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- SILCS diaphragm used with ContraGel, SILCS diaphragm used with 3% Nonoxynol-9 and SILCS diaphragm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2014to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-45 years, inclusive
- General good health, by volunteer history and per investigator judgment
- History of regular menstrual cycles of 24-35 days (inclusive), by volunteer report
- 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
- Willing to abstain from intercourse and use of vaginal products as required in the protocol
- Willing to use non-spermicidal, lubricated condoms from the first day of each menstrual cycle until 72 hours before expected midcycle
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- 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
- Protected from pregnancy by female tubal sterilization
- Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to easy genital tract sample collection
- Willing to give voluntary consent, sign an informed consent form and comply with study procedures as required by the protocol
Who cannot join
- History of hysterectomy
- Vasectomy in male partner
- Sterility or known history of sperm dysfunction in male partner
- 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
- Current use of any hormonal contraceptive or a copper IUD, or use of Depo-Provera in the last 120 days
- Currently breastfeeding or having breastfed an infant in the last two months, or planning to breastfeed during the course of the study
Show all 19Show fewer
- Significant gynecological abnormalities (including abnormal vaginal bleeding or excessive vaginal discharge)
- Device does not appropriately fit volunteer, as determined by clinician
- Inability to insert, position, and/or remove study device, by clinician or volunteer
- History of sensitivity/allergy to 3% N-9, latex, ingredients in ContraGel, or silicone, for either the volunteer or her male partner
- 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
- Positive test for Trichomonas vaginalis, Neisseria gonorrhea or Chlamydia trachomatis
- Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or vesicles suspicious for a sexually transmitted infection
- Positive test for HIV
- Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting, etc.)
- Known current drug or alcohol abuse which could impact study compliance
- Participation in any other investigational trial within the last 30 days or planned participation in any other investigational trial during the study
- History of gynecological procedures (including genital piercing) on the external genitalia, vagina or cervix within the last 14 days
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Clinical Research Center, Eastern Virginia Medical School
Norfolk, Virginia, 23507
About this study
Official title: A Phase I Postcoital Testing Study of the SILCS Diaphragm Used With 3% Nonoxynol-9 Gel, ContraGel, or No Gel
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.
Read the 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:
- 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.
- 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.
- Conditions
- Contraception
- Being tested
- SILCS diaphragm used with ContraGel, SILCS diaphragm used with 3% Nonoxynol-9, SILCS diaphragm
- Keywords
- Contraception, Post coital test, Vaginal, Diaphragm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SILCS diaphragm used with ContraGelOther
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.
SILCS diaphragm used with 3% Nonoxynol-9Other
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.
SILCS diaphragmOther
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
| Study group | Role | What they receive |
|---|---|---|
| SILCS Diaphragm alone | Active comparator | Participants will complete a post-coital test cycle with SILCS diaphragm alone. Receives: Other: SILCS diaphragm |
| SILCS Diaphragm with 3% Nonoxynol-9 Gel | Active comparator | Participants will complete a post-coital test cycle with SILCS diaphragm used with 3% nonoxynol-9 gel. Receives: Other: SILCS diaphragm used with 3% Nonoxynol-9; Other: SILCS diaphragm |
| SILCS Diarphragm with ContraGel | Experimental | Participants will complete a post-coital test cycle with SILCS diaphragm used with ContraGel. Receives: Other: SILCS diaphragm used with ContraGel; Other: SILCS diaphragm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women with an average of fewer than 5 progressively motile sperm per high powered field (HPF) as a measure of preliminary effectiveness
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.
Measured: 2-3 hours following coitus
Per-women average number (across 9 HPFs) of progressively motile sperm per HPF as a measure of preliminary effectiveness.
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.
Measured: 2-3 hours following coitus
Secondary outcomes (2)
Number of treatment emergent adverse experiences among female participants as a measure of safety
Urogenital, product-related, and/or serious AEs will be assessed
Measured: Beginning at Visit 2 through 7-10 days after the final study visit; an average of 6-8 months
Number of treatment emergent adverse experiences among male partners as a measure of safety
Urogenital, product-related, and/or serious AEs will be assessed
Measured: Beginning at Visit 2 through 7-10 days after the final study visit; an average of 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- CONRAD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309554
- Sponsor's protocol ID
- A13-126
- Status last verified
- Jul 2016
- First submitted
- 14 Jul 2014
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Postcoital Testing Study of the SILCS Diaphragm Used With 3% Nonoxynol-9 Gel, ContraGel, or No Gel
- ClinicalTrials.gov ID
- NCT02309554
- Acronym / sponsor ID
- A13-126
- Conditions
- Contraception
- Keywords
- Contraception, Post coital test, Vaginal, Diaphragm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- CONRADUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SILCS Diaphragm alone | Active comparator | Other: SILCS diaphragmParticipants will complete a post-coital test cycle with SILCS diaphragm alone. |
| SILCS Diaphragm with 3% Nonoxynol-9 Gel | Active comparator | Other: SILCS diaphragm used with 3% Nonoxynol-9, Other: SILCS diaphragmParticipants will complete a post-coital test cycle with SILCS diaphragm used with 3% nonoxynol-9 gel. |
| SILCS Diarphragm with ContraGel | Experimental | Other: SILCS diaphragm used with ContraGel, Other: SILCS diaphragmParticipants will complete a post-coital test cycle with SILCS diaphragm used with ContraGel. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age 18-45 years, inclusive
- General good health, by volunteer history and per investigator judgment
- History of regular menstrual cycles of 24-35 days (inclusive), by volunteer report
- 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
- Willing to abstain from intercourse and use of vaginal products as required in the protocol
Key exclusion criteria (19 listed)
- History of hysterectomy
- Vasectomy in male partner
- Sterility or known history of sperm dysfunction in male partner
- 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
- Current use of any hormonal contraceptive or a copper IUD, or use of Depo-Provera in the last 120 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SILCS diaphragm used with ContraGelSILCS 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 Diarphragm with ContraGel |
| SILCS diaphragm used with 3% Nonoxynol-9SILCS 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 with 3% Nonoxynol-9 Gel |
| SILCS diaphragmSILCS 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 | Other | SILCS Diaphragm alone, SILCS Diaphragm with 3% Nonoxynol-9 Gel, SILCS Diarphragm with ContraGel |
Primary outcome
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.
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SILCS diaphragm used with ContraGel, SILCS diaphragm used with 3% Nonoxynol-9 and SILCS diaphragm in people with Contraception, run by CONRAD at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2016.