NCT00429806

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2007

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

4 months

First QC Date

January 31, 2007

Last Update Submit

April 6, 2017

Conditions

Vaginal Atrophy

Keywords

Vaginal atrophyDHEAPrasteroneMenopause

Outcome Measures

Primary Outcomes (2)

  • The evaluation of the systemic bioavailability of DHEA and its metabolites.

    Day 1-2 and Day 7-8

  • The pharmacokinetics of vaginal suppositories at four different DHEA concentrations.

    Day 1-2 and Day 7-8

Secondary Outcomes (2)

  • The safety and tolerance of the suppositories.

    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

    Day 7

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo suppository; once daily for 7 days.

Drug: Placebo

DHEA 0.50%

EXPERIMENTAL

DHEA 0.50% (6.5 mg) suppository; once daily for 7 days.

Drug: DHEA

DHEA 1.0%

EXPERIMENTAL

DHEA 1.0% (13 mg) suppository; once daily for 7 days.

Drug: DHEA

DHEA 1.8%

EXPERIMENTAL

DHEA 1.8% (23.4 mg) suppository; once daily for 7 days.

Drug: DHEA

Interventions

DHEADRUG

DHEA

Also known as: dehydroepiandrosterone; prasterone
DHEA 0.50%DHEA 1.0%DHEA 1.8%
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age40 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique des traitements hormonaux CHUL Research Center

Québec, Quebec, G1V 4G2, Canada

Location

Related Publications (3)

  • 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.

    PMID: 18598765RESULT

  • Labrie 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.

    PMID: 23954500RESULT

  • 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: 10.1515/hmbci-2016-0042.

    PMID: 27997350RESULT

MeSH Terms

Interventions

Dehydroepiandrosterone

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds17-KetosteroidsKetosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsTestosterone CongenersGonadal Steroid HormonesGonadal Hormones

Study Officials

  • Fernand Labrie, MD, Ph D

    CHUL Research Center Director

    STUDY CHAIR

  • Cusan Leonello, MD Ph D

    CHUL Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2007

First Posted

February 1, 2007

Study Start

November 1, 2006

Primary Completion

March 1, 2007

Study Completion

July 1, 2007

Last Updated

April 7, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)