Vaginal Atrophy Clinical Trial
Official title:
DHEA Bioavailability Following Administration of Vaginal Suppositories in Post-Menopausal Women With Vaginal Atrophy-Phase I Randomized,Placebo-Controlled, Double-Blind Study.
Verified date | April 2017 |
Source | Centre Hospitalier Universitaire de Québec, CHU de Québec |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | July 2007 |
Est. primary completion date | March 2007 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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, - Use of natural (phytoestrogens) or herbal products in the 2 weeks prior to baseline, - Chronic use of corticosteroids, - Hypertension not controlled by standard therapy. |
Country | Name | City | State |
---|---|---|---|
Canada | Clinique des traitements hormonaux CHUL Research Center | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Québec, CHU de Québec |
Canada,
Labrie F, Cusan L, Gomez JL, Côté I, Bérubé R, Bélanger 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 — View Citation
Labrie F, Martel C, Bérubé R, Côté 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- — View Citation
Labrie 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The evaluation of the systemic bioavailability of DHEA and its metabolites. | Day 1-2 and Day 7-8 | ||
Primary | The pharmacokinetics of vaginal suppositories at four different DHEA concentrations. | Day 1-2 and Day 7-8 | ||
Secondary | The safety and tolerance of the suppositories. | Day 1 to Day 8 (plus follow-up of Adverse Events for 30 days after last dose) | ||
Secondary | The effect of treatment on maturation index and value | Day 7 |
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