Vaginal AtrophyPhase 1NCT00429806
DHEA Bioavailability Following Administration of Vaginal Suppositories in Post-Menopausal Women With Vaginal Atrophy
A Phase 1 study testing DHEA in people with Vaginal Atrophy, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
The purpose of the study is to evaluate the systemic bioavailability of DHEA and its metabolites and the pharmacokinetics of vaginal suppositories at four different DHEA concentration. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Vaginal Atrophy
- What is being tested?
- DHEA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2006to Jul 2007
- 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 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women,
- Experiencing one symptom of vaginal atrophy (vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity or vaginal bleeding associated with sexual activity,
- Women having a low maturation index and a vaginal pH above 5,
- Endometrial thickness of 4 mm or less at transvaginal ultrasonography,
- Body weight within 18.5 and 32.0 according to body mass index.
Who cannot join
- Undiagnosed abnormal genital bleeding,
- Active or history of thromboembolic disease,
- Significant metabolic or endocrine disease,
- Significant complication on previous hormonal therapy,
- Use of hormonal implants within 6 months prior to study entry,
- Use of oral estrogen, progestin or DHEA in the 8 weeks prior to baseline,
Show all 9Show fewer
- Use of natural (phytoestrogens) or herbal products in the 2 weeks prior to baseline,
- Chronic use of corticosteroids,
- Hypertension not controlled by standard therapy.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinique des traitements hormonaux CHUL Research Center
Québec, Quebec, G1V 4G2
About this study
Official title: DHEA Bioavailability Following Administration of Vaginal Suppositories in Post-Menopausal Women With Vaginal Atrophy-Phase I Randomized,Placebo-Controlled, Double-Blind Study.
The purpose of the study is to evaluate the systemic bioavailability of DHEA and its metabolites and the pharmacokinetics of vaginal suppositories at four different DHEA concentration.
Read the detailed description
Humans, are unique among animal species in having adrenals that secrete large amounts of the inactive precursor steroids dehydroepiandrosterone (DHEA) and especially its sulfate DHEA-S. The marked reduction in the formation of DHEA-S by the adrenals during aging results in a dramatic fall in the formation of androgens and estrogens in peripheral target tissues, a situation that has been proposed to be associated with age-related diseases including skin atrophy, insulin resistance and obesity. Much attention has been given to the benefits of DHEA administered to postmenopausal women, especially on the bone, skin, vagina and well being after oral as well as percutaneous administration of the precursor steroid.
Therefore, this study proposes to evaluate the systemic bioavailability and the effectiveness of 1.3 mL vaginal suppositories of DHEA at 4 different concentrations (0.0%, 0.5%, 1.0% et 1.8%) following 1 week administration of vaginal suppositories in post-menopausal women with vaginal atrophy. This is a phase I, randomized, placebo-controlled, double-blind study.
- Conditions
- Vaginal Atrophy
- Being tested
- DHEA, Placebo
- Keywords
- Vaginal atrophy, DHEA, Prasterone, Menopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHEADrug
Also called dehydroepiandrosterone; prasterone
DHEA
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo suppository; once daily for 7 days. Receives: Drug: Placebo |
| DHEA 0.50% | Experimental | DHEA 0.50% (6.5 mg) suppository; once daily for 7 days. Receives: Drug: DHEA |
| DHEA 1.0% | Experimental | DHEA 1.0% (13 mg) suppository; once daily for 7 days. Receives: Drug: DHEA |
| DHEA 1.8% | Experimental | DHEA 1.8% (23.4 mg) suppository; once daily for 7 days. Receives: Drug: DHEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation of the systemic bioavailability of DHEA and its metabolites.
Measured: Day 1-2 and Day 7-8
The pharmacokinetics of vaginal suppositories at four different DHEA concentrations.
Measured: Day 1-2 and Day 7-8
Secondary outcomes (2)
The safety and tolerance of the suppositories.
Measured: Day 1 to Day 8 (plus follow-up of Adverse Events for 30 days after last dose)
The effect of treatment on maturation index and value
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startNov 2006
- Primary completionMar 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vaginal AtrophyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernand Labrie, MD, Ph D, Study chair, CHUL Research Center DirectorCusan Leonello, MD Ph D, Principal investigator, CHUL Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429806
- Sponsor's protocol ID
- ERC-213
- Status last verified
- Apr 2017
- First submitted
- 31 Jan 2007
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Labrie F, Cusan L, Gomez JL, Cote I, Berube R, Belanger P, Martel C, Labrie C. Effect of intravaginal DHEA on serum DHEA and eleven of its metabolites in postmenopausal women. J Steroid Biochem Mol Biol. 2008 Sep;111(3-5):178-94. doi: 10.1016/j.jsbmb.2008.06.003. Epub 2008 Jun 12.
PubMed 18598765Labrie F, Martel C, Berube R, Cote I, Labrie C, Cusan L, Gomez JL. Intravaginal prasterone (DHEA) provides local action without clinically significant changes in serum concentrations of estrogens or androgens. J Steroid Biochem Mol Biol. 2013 Nov;138:359-67. doi: 10.1016/j.jsbmb.2013.08.002. Epub 2013 Aug 14.
PubMed 23954500Labrie F, Martel C. A low dose (6.5 mg) of intravaginal DHEA permits a strictly local action while maintaining all serum estrogens or androgens as well as their metabolites within normal values. Horm Mol Biol Clin Investig. 2017 Feb 1;29(2):39-60. doi: 10.1515/hmbci-2016-0042.
PubMed 27997350
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DHEA Bioavailability Following Administration of Vaginal Suppositories in Post-Menopausal Women With Vaginal Atrophy-Phase I Randomized,Placebo-Controlled, Double-Blind Study.
- ClinicalTrials.gov ID
- NCT00429806
- Acronym / sponsor ID
- ERC-213
- Conditions
- Vaginal Atrophy
- Keywords
- Vaginal atrophy, DHEA, Prasterone, Menopause
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 1 Feb 2007 (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 the study is to evaluate the systemic bioavailability of DHEA and its metabolites and the pharmacokinetics of vaginal suppositories at four different DHEA concentration.
Detailed description
Humans, are unique among animal species in having adrenals that secrete large amounts of the inactive precursor steroids dehydroepiandrosterone (DHEA) and especially its sulfate DHEA-S. The marked reduction in the formation of DHEA-S by the adrenals during aging results in a dramatic fall in the formation of androgens and estrogens in peripheral target tissues, a situation that has been proposed to be associated with age-related diseases including skin atrophy, insulin resistance and obesity. Much attention has been given to the benefits of DHEA administered to postmenopausal women, especially on the bone, skin, vagina and well being after oral as well as percutaneous administration of the precursor steroid.
Therefore, this study proposes to evaluate the systemic bioavailability and the effectiveness of 1.3 mL vaginal suppositories of DHEA at 4 different concentrations (0.0%, 0.5%, 1.0% et 1.8%) following 1 week administration of vaginal suppositories in post-menopausal women with vaginal atrophy. This is a phase I, randomized, placebo-controlled, double-blind study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo suppository; once daily for 7 days. |
| DHEA 0.50% | Experimental | Drug: DHEADHEA 0.50% (6.5 mg) suppository; once daily for 7 days. |
| DHEA 1.0% | Experimental | Drug: DHEADHEA 1.0% (13 mg) suppository; once daily for 7 days. |
| DHEA 1.8% | Experimental | Drug: DHEADHEA 1.8% (23.4 mg) suppository; once daily for 7 days. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Postmenopausal women,
- Experiencing one symptom of vaginal atrophy (vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity or vaginal bleeding associated with sexual activity,
- Women having a low maturation index and a vaginal pH above 5,
- Endometrial thickness of 4 mm or less at transvaginal ultrasonography,
- Body weight within 18.5 and 32.0 according to body mass index.
Key exclusion criteria (9 listed)
- Undiagnosed abnormal genital bleeding,
- Active or history of thromboembolic disease,
- Significant metabolic or endocrine disease,
- Significant complication on previous hormonal therapy,
- Use of hormonal implants within 6 months prior to study entry,
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 |
|---|---|---|
| DHEAAlso: dehydroepiandrosterone; prasteroneDHEA | Drug | DHEA 0.50%, DHEA 1.0%, DHEA 1.8% |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
The evaluation of the systemic bioavailability of DHEA and its metabolites.
Time frame: Day 1-2 and Day 7-8
The pharmacokinetics of vaginal suppositories at four different DHEA concentrations.
Time frame: Day 1-2 and Day 7-8
2 secondary outcomes
The safety and tolerance of the suppositories.
Time frame: Day 1 to Day 8 (plus follow-up of Adverse Events for 30 days after last dose)
The effect of treatment on maturation index and value
Time frame: Day 7
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 7 Apr 2017.
- Results publication: PubMed 18598765Labrie F, Cusan L, Gomez JL, Cote I, Berube R, Belanger P, Martel C, Labrie C. Effect of intravaginal DHEA on serum DHEA and eleven of its metabolites in postmenopausal women. J Steroid Biochem Mol Biol. 2008 Sep;111(3-5):178-94. doi: 10.1016/j.jsbmb.2008.06.003. Epub 2008 Jun 12.
- Results publication: PubMed 23954500Labrie F, Martel C, Berube R, Cote I, Labrie C, Cusan L, Gomez JL. Intravaginal prasterone (DHEA) provides local action without clinically significant changes in serum concentrations of estrogens or androgens. J Steroid Biochem Mol Biol. 2013 Nov;138:359-67. doi: 10.1016/j.jsbmb.2013.08.002. Epub 2013 Aug 14.
- Results publication: PubMed 27997350Labrie F, Martel C. A low dose (6.5 mg) of intravaginal DHEA permits a strictly local action while maintaining all serum estrogens or androgens as well as their metabolites within normal values. Horm Mol Biol Clin Investig. 2017 Feb 1;29(2):39-60. doi: 10.1515/hmbci-2016-0042.
- Individual participant dataSharing planned: No
Related trials for Vaginal Atrophy
RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
RecruitingPhase 3
Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial
Vaginal Atrophy, Breast Carcinoma
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Recruiting
A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Female Urogenital Diseases, Breast Cancer Female
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
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.
Fernand Labrie, MD, Ph D study chair
CHUL Research Center Director
Cusan Leonello, MD Ph D principal investigator
CHUL Research Center
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 DHEA in people with Vaginal Atrophy, run by CHU de Quebec-Universite Laval at 1 site in Canada.
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 5 inclusion and 9 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 7 Apr 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 Canada. 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?
The evaluation of the systemic bioavailability of DHEA and its metabolites. (time frame: Day 1-2 and Day 7-8). 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 NCT00429806, which also lists 3 linked publications.
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 7 Apr 2017.