ContraceptionPhase 1NCT02462954
A Safety Study Of The Caya® Diaphragm Used With ContraGel®
A Phase 1 study testing ContraGel in people with Contraception, run by CONRAD at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety of ContraGel versus the hydroxyethylcellulose (HEC) Universal Placebo gel when used with the Caya diaphragm during two 7-day periods of daily use, the first without intercourse and the second with intercourse. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- ContraGel
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Apr 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers must meet all of the following criteria prior to genital sampling at Visit 2.
- Age 18-50 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 and engage in intercourse and abstain from the use of vaginal products as required in the protocol
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- In a mutually monogamous relationship for at least the last four months with a male partner who:
- Is at least 18 years old
- Is willing and able to comply with protocol requirements including sexual activity/abstinence requirements
- Can engage in vaginal intercourse with the participant without condoms, as specified in protocol
- Has no known risk for sexually transmitted infections (STIs)
- Has no known history of sensitivity/allergy to any component of ContraGel, HEC placebo gel, silicone or nylon
- Protected from pregnancy by female sterilization
- Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to easy colposcopy and 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
- Volunteers must meet none of the following criteria prior to genital sampling at Visit 2.
- History of hysterectomy
- 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 (oral, transdermal, transvaginal, implant, or hormonal intrauterine contraceptive device) or a copper intrauterine device (IUD), or use of Depo-Provera in the last 6 months
- Currently breastfeeding or having breastfed an infant in the last two months, or planning to breastfeed during the course of the study
- Significant gynecological abnormalities (including abnormal vaginal bleeding or excessive vaginal discharge)
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- Caya diaphragm does not appropriately fit volunteer, as determined by clinician
- Inability to insert, position, and/or remove Caya diaphragm by volunteer
- History of sensitivity/allergy to any component of ContraGel, HEC placebo gel, K-Y® Jelly, topical anesthetic, silicone or nylon, and to both silver nitrate and Monsel's solution
- In the last six months, either the volunteer or her male partner diagnosed with or treated for any STI or pelvic inflammatory disease by self report. Note: Women with a history of genital herpes or condylomata who have been asymptomatic for at least six months may be considered for eligibility
- Nugent score greater than or equal to 7
- Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis, or HIV
- Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or vesicles suspicious for a sexually transmitted infection
- Known bleeding disorder that could lead to prolonged or continuous bleeding with biopsy
- Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting/bleeding, discharge, 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
- Systemic use in the last two weeks or anticipated use during the study of any of the following: corticosteroids, antibiotics, anticoagulants or other drugs known to prolong bleeding and/or clotting, antifungals, or antivirals (e.g. acyclovir or valacyclovir). Note: Participants should avoid non-steroidal anti-inflammatory drugs (NSAIDs) except for treatment of dysmenorrhea during menses. Participants may use Tylenol on an as-needed but not daily basis during the study
- Grade 2 or higher abnormality per the November 2014 update of the Division of AIDS, National Institute of Allergy and Infectious Disease (DAIDS) Table for Grading of the Severity of Adverse Events or clinically significant lab abnormalities as determined by clinician
- 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
1 site in 1 country.
United States1 site
Eastern Virginia Medical School
Norfolk, Virginia, 23507
About this study
Official title: A Phase I Safety Study Of The Caya® Diaphragm Used With ContraGel®
The purpose of this study is to evaluate the safety of ContraGel versus the hydroxyethylcellulose (HEC) Universal Placebo gel when used with the Caya diaphragm during two 7-day periods of daily use, the first without intercourse and the second with intercourse.
Read the detailed description
This single-center randomized, parallel, Phase I study will compare the safety of ContraGel delivered by the Caya diaphragm versus HEC universal placebo gel delivered by the Caya diaphragm in approximately 24 healthy premenopausal women protected from pregnancy by female sterilization. Women will use the assigned product during two 7-day periods of daily use, the first without intercourse and the second with intercourse.
Each woman will be seen in approximately 6 visits and will be contacted via one scheduled follow-up call after Visit 6.
At Visit 1, volunteers will be consented and undergo procedures to confirm they are eligible to continue in the study.
At Visit 2, once it has been confirmed that the participant meets all of the inclusion criteria and none of the exclusion criteria, baseline genital tract samples will be taken.
At Visit 3,baseline genital tract samples will be taken for Test Cycle 1 (before product use with no intercourse). Participants will be randomized in a 1:1 ratio to insert the Caya diaphragm to deliver either ContraGel or the HEC placebo every day for two 7-day periods in two separate menstrual cycles. The participant will receive study supplies. She will be instructed to refrain from intercourse during the first 7-day period and to insert the Caya each day for between 6-12 hours. She will be instructed to return to the clinic at Visit 4 with the diaphragm in place.
At Visit 4, genital tract samples will be taken after 7 days of product use without intercourse (Test Cycle 1).
At Visit 5, baseline genital tract samples will be taken for Test Cycle 2 (before product use with intercourse). The participant will receive study supplies and will be instructed to engage in two sex acts during this 7-day period, the second sex act to take place using the study products 6-12 hours prior to Visit 6. Participants will be instructed to return to the clinic at Visit 6 with the diaphragm still in place.
At Visit 6, genital tract samples will be taken after 7 days of product use with intercourse (Test Cycle 2).
A follow-up call/contact will be scheduled for 1 to 2 weeks after Visit 6. The participant will be asked about any adverse events (AEs) experienced and medications taken since the last visit. The participant will then be exited from the study, unless she has symptoms that require follow-up.
- Conditions
- Contraception
- Being tested
- ContraGel, HEC Universal Placebo gel
- Keywords
- Contraception, Vaginal Gel, Diaphragm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ContraGelDevice
HEC Universal Placebo gelDevice
| Study group | Role | What they receive |
|---|---|---|
| ContraGel | Experimental | ContraGel, a personal lubricant has a Conformite Europeenne (CE) mark and has been used with barrier devices in Europe and other countries outside the US, but it is not currently approved by the US FDA. Receives: Device: ContraGel |
| HEC Placebo | Placebo comparator | The placebo gel is supplied by CONRAD in pre-filled individual applicators, each applicator containing 4.0 mL of HEC gel. Placebo gel contains HEC as the gel thickener, purified water, sodium chloride, sorbic acid and sodium hydroxide. Receives: Device: HEC Universal Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse experiences (TEAEs) among female participants: urogenital, product-related, and/or serious
Measured: after two 7-day periods of daily use, the first without intercourse and the second with intercourse
Changes from baseline in the following safety endpoints [composite]:
- Findings on pelvic exam, including colposcopy
- Vaginal pH (measure of acidity and alkalinity), Nugent score, and microflora
- Anti-bacterial activity in cervicovaginal fluid (CVF)
- Soluble markers of inflammation in cervicovaginal fluid (CVF)
- Epithelial integrity and immune cell activation/phenotype in genital tissues
- Findings on pelvic exam, including colposcopy
- Vaginal pH, Nugent score, and microflora
- Anti-bacterial activity in cervicovaginal fluid (CVF)
- Soluble markers of inflammation in cervicovaginal fluid (CVF)
- Epithelial integrity and immune cell activation/phenotype in genital tissues
Measured: after two 7-day periods of daily use, the first without intercourse and the second with intercourse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- CONRAD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Mauck, Study director, CONRAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462954
- Sponsor's protocol ID
- A13-127
- Status last verified
- May 2016
- First submitted
- 27 May 2015
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Thurman A, Cunningham T, Fichorova R, Herold BC, Hillier SL, Chandra N, Doncel GF. A phase I randomized safety study of a single-size silicone rubber diaphragm used with or without a lactic-acid-containing diaphragm gel. Contraception. 2019 Dec;100(6):430-437. doi: 10.1016/j.contraception.2019.06.004. Epub 2019 Aug 21.
PubMed 31442441
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Safety Study Of The Caya® Diaphragm Used With ContraGel®
- ClinicalTrials.gov ID
- NCT02462954
- Acronym / sponsor ID
- A13-127
- Conditions
- Contraception
- Keywords
- Contraception, Vaginal Gel, Diaphragm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- CONRADUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 4 Jun 2015 (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.
The purpose of this study is to evaluate the safety of ContraGel versus the hydroxyethylcellulose (HEC) Universal Placebo gel when used with the Caya diaphragm during two 7-day periods of daily use, the first without intercourse and the second with intercourse.
Detailed description
This single-center randomized, parallel, Phase I study will compare the safety of ContraGel delivered by the Caya diaphragm versus HEC universal placebo gel delivered by the Caya diaphragm in approximately 24 healthy premenopausal women protected from pregnancy by female sterilization. Women will use the assigned product during two 7-day periods of daily use, the first without intercourse and the second with intercourse.
Each woman will be seen in approximately 6 visits and will be contacted via one scheduled follow-up call after Visit 6.
At Visit 1, volunteers will be consented and undergo procedures to confirm they are eligible to continue in the study.
At Visit 2, once it has been confirmed that the participant meets all of the inclusion criteria and none of the exclusion criteria, baseline genital tract samples will be taken.
At Visit 3,baseline genital tract samples will be taken for Test Cycle 1 (before product use with no intercourse). Participants will be randomized in a 1:1 ratio to insert the Caya diaphragm to deliver either ContraGel or the HEC placebo every day for two 7-day periods in two separate menstrual cycles. The participant will receive study supplies. She will be instructed to refrain from intercourse during the first 7-day period and to insert the Caya each day for between 6-12 hours. She will be instructed to return to the clinic at Visit 4 with the diaphragm in place.
At Visit 4, genital tract samples will be taken after 7 days of product use without intercourse (Test Cycle 1).
At Visit 5, baseline genital tract samples will be taken for Test Cycle 2 (before product use with intercourse). The participant will receive study supplies and will be instructed to engage in two sex acts during this 7-day period, the second sex act to take place using the study products 6-12 hours prior to Visit 6. Participants will be instructed to return to the clinic at Visit 6 with the diaphragm still in place.
At Visit 6, genital tract samples will be taken after 7 days of product use with intercourse (Test Cycle 2).
A follow-up call/contact will be scheduled for 1 to 2 weeks after Visit 6. The participant will be asked about any adverse events (AEs) experienced and medications taken since the last visit. The participant will then be exited from the study, unless she has symptoms that require follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ContraGel | Experimental | Device: ContraGelContraGel, a personal lubricant has a Conformite Europeenne (CE) mark and has been used with barrier devices in Europe and other countries outside the US, but it is not currently approved by the US FDA. |
| HEC Placebo | Placebo comparator | Device: HEC Universal Placebo gelThe placebo gel is supplied by CONRAD in pre-filled individual applicators, each applicator containing 4.0 mL of HEC gel. Placebo gel contains HEC as the gel thickener, purified water, sodium chloride, sorbic acid and sodium hydroxide. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Volunteers must meet all of the following criteria prior to genital sampling at Visit 2.
Key exclusion criteria (21 listed)
- Volunteers must meet none of the following criteria prior to genital sampling at Visit 2.
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 |
|---|---|---|
| ContraGel | Device | ContraGel |
| HEC Universal Placebo gel | Device | HEC Placebo |
Primary outcome
Treatment-emergent adverse experiences (TEAEs) among female participants: urogenital, product-related, and/or serious
Time frame: after two 7-day periods of daily use, the first without intercourse and the second with intercourse
Changes from baseline in the following safety endpoints [composite]:
Time frame: after two 7-day periods of daily use, the first without intercourse and the second with intercourse
* Findings on pelvic exam, including colposcopy * Vaginal pH (measure of acidity and alkalinity), Nugent score, and microflora * Anti-bacterial activity in cervicovaginal fluid (CVF) * Soluble markers of inflammation in cervicovaginal fluid (CVF) * Epithelial integrity and immune cell activation/phenotype in genital tissues * Findings on pelvic exam, including colposcopy * Vaginal pH, Nugent score, and microflora * Anti-bacterial activity in cervicovaginal fluid (CVF) * Soluble markers of inflammation in cervicovaginal fluid (CVF) * Epithelial integrity and immune cell activation/phenotype in genital tissues
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 27 May 2016.
- Derived from this study: PubMed 31442441Thurman A, Cunningham T, Fichorova R, Herold BC, Hillier SL, Chandra N, Doncel GF. A phase I randomized safety study of a single-size silicone rubber diaphragm used with or without a lactic-acid-containing diaphragm gel. Contraception. 2019 Dec;100(6):430-437. doi: 10.1016/j.contraception.2019.06.004. Epub 2019 Aug 21.
- Individual participant dataSharing planned: No
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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.
Christine Mauck study director
CONRAD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ContraGel in people with Contraception, run by CONRAD at 1 site in United States.
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 15 inclusion and 21 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 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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?
Treatment-emergent adverse experiences (TEAEs) among female participants: urogenital, product-related, and/or serious (time frame: after two 7-day periods of daily use, the first without intercourse and the second with intercourse). 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?
On the ClinicalTrials.gov record for NCT02462954, which also lists 1 linked publication.
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 27 May 2016.