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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT00429806
First received: January 31, 2007
Last updated: March 19, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Vaginal Atrophy
Drug: DHEA
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: DHEA Bioavailability Following Administration of Vaginal Suppositories in Post-Menopausal Women With Vaginal Atrophy-Phase I Randomized,Placebo-Controlled, Double-Blind Study.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

Primary Outcome Measures:
  • The evaluation of the systemic bioavailability of DHEA and its metabolites. [ Time Frame: Day 1-2 and Day 7-8 ] [ Designated as safety issue: No ]
  • The pharmacokinetics of vaginal suppositories at four different DHEA concentrations. [ Time Frame: Day 1-2 and Day 7-8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
  • The effect of treatment on maturation index and value [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: November 2006
Study Completion Date: July 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo suppository; once daily for 7 days.
Drug: Placebo
Placebo
Experimental: DHEA 0.50%
DHEA 0.50% (6.5 mg) suppository; once daily for 7 days.
Drug: DHEA
DHEA
Other Name: dehydroepiandrosterone; prasterone
Experimental: DHEA 1.0%
DHEA 1.0% (13 mg) suppository; once daily for 7 days.
Drug: DHEA
DHEA
Other Name: dehydroepiandrosterone; prasterone
Experimental: DHEA 1.8%
DHEA 1.8% (23.4 mg) suppository; once daily for 7 days.
Drug: DHEA
DHEA
Other Name: dehydroepiandrosterone; prasterone

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429806

Locations
Canada
Clinique des traitements hormonaux CHUL Research Center
Quebec, Canada, G1V 4G2
Sponsors and Collaborators
Centre Hospitalier Universitaire de Québec, CHU de Québec
Investigators
Study Chair: Fernand Labrie, MD, Ph D CHUL Research Center Director
Principal Investigator: Cusan Leonello, MD Ph D CHUL Research Center
  More Information

Publications:
Responsible Party: Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier: NCT00429806     History of Changes
Other Study ID Numbers: ERC-213 
Study First Received: January 31, 2007
Last Updated: March 19, 2016
Health Authority: Canada: Health Canada
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:
Vaginal atrophy
DHEA
Prasterone
Menopause

Additional relevant MeSH terms:
Atrophy
Pathological Conditions, Anatomical
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016