Vaginal DiseasesNCT02534779
Assessing the Disintegration, Safety, and Acceptability of Placebo Vaginal Inserts for the Delivery of Vaginal Products
A study of Vaginal Diseases, run by CONRAD at 1 site in United States.
Trial summary
This open-label study will examine the disintegration/disappearance time, safety, and acceptability of placebo vaginal inserts. Participants will use a placebo vaginal insert twice: first for an in-clinic disintegration/safety assessment, and a second time for an at-home acceptability assessment, with safety assessed… 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
- Vaginal Diseases
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Mar 2016
- Phase
- Interventional
- 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
- Age 18-50 years, inclusive
- General good health (by volunteer history and investigator judgment)
- Currently having regular menstrual cycles of 21 - 35 days by volunteer report
- Protected from pregnancy, meaning one of the following: Sexually abstinent and planning to remain abstinent for the duration of the study; In a monogamous heterosexual relationship for at least four months with a partner who is not known to be HIV positive and has no known risks for sexually transmitted infections (STIs) and: Couple is using condoms and is willing to use non-spermicidally lubricated condoms throughout the study or One partner is sterilized; or in a monogamous same-sex relationship for at least four months with a partner who is not known to be HIV positive and has no known risks for STIs.
- Willing to abstain from vaginal activity and vaginal product use as required in the protocol
- Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to easy examination
- 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
- 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
- Use of any hormonal contraceptive method in the last 30 days (oral, transdermal, transvaginal, implant, or hormonal intrauterine contraceptive device)
- Injection of Depo-Provera in the last 6 months
- Current use of copper intrauterine device (IUD)
- Currently breastfeeding or having breastfed an infant in the last two months, or planning to breastfeed during the course of the study
Show all 13Show fewer
- History of sensitivity/allergy to any component of the study products
- Symptomatic reproductive tract infection (RTI)
- 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 (device, drug, or vaginal 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 physical examination or a social or medical condition 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
This open-label study will examine the disintegration/disappearance time, safety, and acceptability of placebo vaginal inserts. Participants will use a placebo vaginal insert twice: first for an in-clinic disintegration/safety assessment, and a second time for an at-home acceptability assessment, with safety assessed at the following clinic visit.
Read the detailed description
This open-label study will examine the disintegration/disappearance time, safety, and acceptability of placebo vaginal inserts. Participants will use a placebo vaginal insert twice: first for an in-clinic disintegration/safety assessment, and a second time for an at-home acceptability assessment, with safety assessed at the following clinic visit.
Participants will be assigned to test their insert during either the follicular or luteal phase of their menstrual cycle, such that the number of women who test it in the follicular phase is approximately equal to the number who test it in the luteal phase.
Once eligibility has been confirmed, the participant will complete an in-clinic disintegration test to estimate the amount of time required for disintegration and complete disappearance of the vaginal insert. Prior to and following the disintegration test, the participant will have a pelvic exam and vaginal swab(s) will be collected for development of adherence measures. Safety will be assessed by naked eye exam and report of adverse events (AEs).
24 to 72 hours following the in-clinic disintegration test, the participant will use the vaginal insert at home and complete a standardized acceptability questionnaire 4 hours and 24 hours after placement. The acceptability questionnaire will be returned to the clinic at the participant's next visit. The final clinic visit will be scheduled 24-72 hours after placement of the vaginal insert used at home.
The final study visit will include a pelvic exam to assess safety and vaginal swab(s) will be collected for development of adherence measures. The participant will exit the study following the final study visit.
This study is designed to test a single placebo vaginal insert, but it is possible additional inserts may become available for testing. Participants may re-enroll in the study for the testing of additional vaginal inserts as they become available.
- Conditions
- Vaginal Diseases
- Being tested
- Placebo Vaginal Insert
- Medical subject headings
- Vaginal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Vaginal InsertOther
Placebo insert
| Study group | Role | What they receive |
|---|---|---|
| Placebo Vaginal Insert | Experimental | Placebo insert Receives: Other: Placebo Vaginal Insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to disintegration (insert no longer coherent but residual product is visible)
Measured: Up to 90 minutes post-insertion
Percent of inserts that partially/fully disintegrate and completely disappear at each time point of observation
Measured: Up to 90 minutes post use
Time to complete disappearance
Measured: Up to 90 minutes post-insertion
Secondary outcomes (2)
Abnormal findings related to study product on pelvic examination by naked eye exam
Measured: Up to 90 minutes post use; 24-72 hours post at-home use
Genitourinary adverse events after use of inserts
Measured: Up to 90 minutes post use; 24-72 hours post at-home use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startAug 2015
- 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 Vaginal DiseasesStudies 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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- CONRAD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jill Schwartz, MD, Study chair, CONRAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534779
- Sponsor's protocol ID
- D15-134
- Status last verified
- Jun 2016
- First submitted
- 21 Aug 2015
- Last updated
- 2 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Disintegration, Safety, and Acceptability of Placebo Vaginal Inserts for the Delivery of Vaginal Products
- ClinicalTrials.gov ID
- NCT02534779
- Acronym / sponsor ID
- D15-134
- Conditions
- Vaginal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- CONRADUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 28 Aug 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.
This open-label study will examine the disintegration/disappearance time, safety, and acceptability of placebo vaginal inserts. Participants will use a placebo vaginal insert twice: first for an in-clinic disintegration/safety assessment, and a second time for an at-home acceptability assessment, with safety assessed at the following clinic visit.
Detailed description
This open-label study will examine the disintegration/disappearance time, safety, and acceptability of placebo vaginal inserts. Participants will use a placebo vaginal insert twice: first for an in-clinic disintegration/safety assessment, and a second time for an at-home acceptability assessment, with safety assessed at the following clinic visit.
Participants will be assigned to test their insert during either the follicular or luteal phase of their menstrual cycle, such that the number of women who test it in the follicular phase is approximately equal to the number who test it in the luteal phase.
Once eligibility has been confirmed, the participant will complete an in-clinic disintegration test to estimate the amount of time required for disintegration and complete disappearance of the vaginal insert. Prior to and following the disintegration test, the participant will have a pelvic exam and vaginal swab(s) will be collected for development of adherence measures. Safety will be assessed by naked eye exam and report of adverse events (AEs).
24 to 72 hours following the in-clinic disintegration test, the participant will use the vaginal insert at home and complete a standardized acceptability questionnaire 4 hours and 24 hours after placement. The acceptability questionnaire will be returned to the clinic at the participant's next visit. The final clinic visit will be scheduled 24-72 hours after placement of the vaginal insert used at home.
The final study visit will include a pelvic exam to assess safety and vaginal swab(s) will be collected for development of adherence measures. The participant will exit the study following the final study visit.
This study is designed to test a single placebo vaginal insert, but it is possible additional inserts may become available for testing. Participants may re-enroll in the study for the testing of additional vaginal inserts as they become available.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Placebo Vaginal Insert | Experimental | Other: Placebo Vaginal InsertPlacebo insert |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-50 years, inclusive
- General good health (by volunteer history and investigator judgment)
- Currently having regular menstrual cycles of 21 - 35 days by volunteer report
- Protected from pregnancy, meaning one of the following: Sexually abstinent and planning to remain abstinent for the duration of the study; In a monogamous heterosexual relationship for at least four months with a partner who is not known to be HIV positive and has no known risks for sexually transmitted infections (STIs) and: Couple is using condoms and is willing to use non-spermicidally lubricated condoms throughout the study or One partner is sterilized; or in a monogamous same-sex relationship for at least four months with a partner who is not known to be HIV positive and has no known risks for STIs.
- Willing to abstain from vaginal activity and vaginal product use as required in the protocol
Key exclusion criteria (13 listed)
- 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
- Use of any hormonal contraceptive method in the last 30 days (oral, transdermal, transvaginal, implant, or hormonal intrauterine contraceptive device)
- Injection of Depo-Provera in the last 6 months
- Current use of copper intrauterine device (IUD)
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 |
|---|---|---|
| Placebo Vaginal InsertPlacebo insert | Other | Placebo Vaginal Insert |
Primary outcome
Time to disintegration (insert no longer coherent but residual product is visible)
Time frame: Up to 90 minutes post-insertion
Percent of inserts that partially/fully disintegrate and completely disappear at each time point of observation
Time frame: Up to 90 minutes post use
Time to complete disappearance
Time frame: Up to 90 minutes post-insertion
2 secondary outcomes
Abnormal findings related to study product on pelvic examination by naked eye exam
Time frame: Up to 90 minutes post use; 24-72 hours post at-home use
Genitourinary adverse events after use of inserts
Time frame: Up to 90 minutes post use; 24-72 hours post at-home use
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 2 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
Jill Schwartz, MD study chair
CONRAD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Vaginal Diseases, 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 7 inclusion and 13 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 2 Jun 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Time to disintegration (insert no longer coherent but residual product is visible) (time frame: Up to 90 minutes post-insertion). The study lists 3 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 2 Jun 2016.