DHEA Bioavailability Following Administration of Vaginal Suppositories in Post-Menopausal Women With Vaginal Atrophy

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00429806
• Other study ID #: ERC-213
• Status: Completed
• Phase: Phase 1
• First received: January 31, 2007
• Last updated: April 6, 2017
• Start date: November 2006
• Est. completion date: July 2007

Study information

• Verified date: April 2017
• Source: Centre Hospitalier Universitaire de Québec, CHU de Québec
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Atrophy
• Vaginal Atrophy

Intervention

Drug:
• DHEA
DHEA
• Placebo
Placebo

Locations

Country	Name	City	State
Canada	Clinique des traitements hormonaux CHUL Research Center	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Québec, CHU de Québec

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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

Outcome

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