Vaginal DrynessPhase 2/3NCT01724242
Vaginal DHEA for Women After Breast Cancer
A Phase 2/3 study testing Vaginal DHEA in people with Vaginal Dryness and Breast Cancer, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
There does not appear to be a consensus regarding the treatment of vaginal dryness in women who have a contraindication to the use of estrogen products. DHEA, when used locally, may improve the symptoms of vaginal dryness due to its chemical properties. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- Vaginal Dryness, Breast Cancer, Urinary Incontinence
- What is being tested?
- Vaginal DHEA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2013to Dec 2014
- Phase
- Phase 2/3
- 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 35 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women post menopausal aged 35-55, suffering from vaginal dryness, secondary to chemotherapy for breast cancer, within 5 years of diagnosis. Follicle Stimulating Hormone and Estradiol levels in the post menopausal range are needed.
Who cannot join
- women using products to alleviate vaginal dryness.
- women taking medication for urinary incontinence
- women not sexually active, for other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaginal DHEA to Ease Vaginal Dryness in Women With a Contraindication to Estrogen Therapy
There does not appear to be a consensus regarding the treatment of vaginal dryness in women who have a contraindication to the use of estrogen products. DHEA, when used locally, may improve the symptoms of vaginal dryness due to its chemical properties.
- Conditions
- Vaginal Dryness, Breast Cancer, Urinary Incontinence, Quality of Life, Sexual Satisfaction
- Being tested
- Vaginal DHEA, Placebo
- Keywords
- Vaginal dryness, Breast Cancer, Urinary Incontinence, Quality of Life, Sexual Satisfaction
- Medical subject headings
- Breast Neoplasms, Urinary Incontinence, Orgasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal DHEADrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Vaginal DHEA | Experimental | Vaginal DHEA 0.5%(6.5mg)inserted nightly Receives: Drug: Vaginal DHEA |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in vaginal dryness
Measured: 12 weeks
Secondary outcomes (2)
improvement in urinary incontinence
Measured: 12 weeks
improvement in sexual satisfaction
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2012 (estimated)
- Study startFeb 2013
- Primary completionJan 2014 (estimated)
- Study completionDec 2014 (estimated)
Why it stopped: Inability to recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DrynessStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Drorith Hochner-Celnikier, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724242
- Sponsor's protocol ID
- DHEA-HMO-CTIL
- Status last verified
- Jul 2015
- First submitted
- 7 Nov 2012
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal DHEA to Ease Vaginal Dryness in Women With a Contraindication to Estrogen Therapy
- ClinicalTrials.gov ID
- NCT01724242
- Acronym / sponsor ID
- DHEA-HMO-CTIL
- Conditions
- Vaginal Dryness, Breast Cancer, Urinary Incontinence, Quality of Life, Sexual Satisfaction
- Keywords
- Vaginal dryness, Breast Cancer, Urinary Incontinence, Quality of Life, Sexual Satisfaction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inability to recruit patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 9 Nov 2012 (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.
There does not appear to be a consensus regarding the treatment of vaginal dryness in women who have a contraindication to the use of estrogen products. DHEA, when used locally, may improve the symptoms of vaginal dryness due to its chemical properties.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal DHEA | Experimental | Drug: Vaginal DHEAVaginal DHEA 0.5%(6.5mg)inserted nightly |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women post menopausal aged 35-55, suffering from vaginal dryness, secondary to chemotherapy for breast cancer, within 5 years of diagnosis. Follicle Stimulating Hormone and Estradiol levels in the post menopausal range are needed.
Key exclusion criteria (3 listed)
- women using products to alleviate vaginal dryness.
- women taking medication for urinary incontinence
- women not sexually active, for other reasons.
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 |
|---|---|---|
| Vaginal DHEA | Drug | Vaginal DHEA |
| Placebo | Drug | Placebo |
Primary outcome
improvement in vaginal dryness
Time frame: 12 weeks
2 secondary outcomes
improvement in urinary incontinence
Time frame: 12 weeks
improvement in sexual satisfaction
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
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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.
Drorith Hochner-Celnikier, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vaginal DHEA in people with Vaginal Dryness and Breast Cancer, run by Hadassah Medical Organization at 1 site in Israel.
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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 28 Nov 2017. 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 Israel. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
improvement in vaginal dryness (time frame: 12 weeks). 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 28 Nov 2017.