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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Centre Hospitalier Universitaire de Québec, CHU de Québec.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT00429806
First received: January 31, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  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
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.
  • The pharmacokinetics of vaginal suppositories at four different DHEA concentrations.

Secondary Outcome Measures:
  • The safety and tolerance of the suppositories.

Estimated Enrollment: 40
Study Start Date: December 2006
Estimated Study Completion Date: January 2007
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
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:
Bélanger, A., Labrie, F., Monfette, G., Dupont, A., and Caron, S. Measurement of non conjugated C-19 steroids as well as C-19 steroid glucuronides in plasma and tissue. First International Symposium on Steroid Formation, Degradation and Action in Peripheral, Normal and Neoplastic Tissues, Taormina (Italy)1989, Abst. 35.
Berger, J. Androgenic effect on vaginal epithelial cells. Acta Cytol, 1: 70-103, 1957.
Franceschi, S. The epidemiology of endometrial cancer. Gynecol. Oncol., 41: 1-16, 1991.
Gallagher, J.C., and Riggs, B.L. Current concepts in nutrition. Nutrition and bone disease. N Engl J Med, 298: 193-5, 1978.
Harris, S.T., Genant, H.K., Baylink, D.J., Gallagher, J.C., Karp, S.K., McConnell, M.A., Green, E.M., and Stoll, R.W. The effects of estrone (Ogen) on spinal bone density of postmenopausal women. Arch. Intern. Med., 151: 1980-1984, 1991.
Hendrix, S.L., Cochrane, B.B., Nygaard, I.E., Handa, V.L., Barnabei, V.M., Iglesia, C., Aragaki, A., Naughton, M.J., Wallace, R.B., and McNeeley, S.G. Effects of estrogen with and without progestin on urinary incontinence. Jama, 293: 935-48, 2005.
Keloff, G.J., Crowell, J.A., Hawk, E.T., Steele, V.E., Lubet, R.A., Boone, C.W., Covey, J.M., Doody, L.A., Omenn, G.S., Greenwald, P., Hong, W.K., Parkinson, D.R., Bagheri, D., Baxter, G.T., Blunden, M., Doeltz, M.K., Eisenhauer, K.M., Johnson, K., Longfellow, K., Longfellow, D.G., Knapp, G.G., Malone, W.F., Nayfeild, S.G., Seifried, H.E., Swall, L.M., and Sigman, C.C. Clinical development plan: genistein. J Cell Biochem Supp, 26: 114-126, 1996.
Labrie, F. Intracrinology. Mol. Cell. Endocrinol., 78: C113-C118, 1991.
Labrie, F. Dehydroepiandrosterone (DHEA) as potential hormone replacement therapy. Référence en Gynécologie Obstétrique, 8: 317-322, 2001.
Labrie, F., Dupont, A., and Bélanger, A. Complete androgen blockade for the treatment of prostate cancer. In: Important Advances in Oncology. de Vita, V.T., Hellman, S. and Rosenberg, S.A. (eds.), Philadelphia, J.B. Lippincott: pp. 193-217, 1985.
Labrie, F., Luu-The, V., Bélanger, A., Lin, S.-X., Simard, J., and Labrie, C. Is DHEA a hormone? Starling Review. J Endocrinol, 187: 169-196, 2005a.
Labrie, F., Simard, J., Luu-The, V., Bélanger, A., and Pelletier, G. Structure, function and tissue-specific gene expression of 3b-hydroxysteroid dehydrogenase/5-ene-4-ene isomerase enzymes in classical and peripheral intracrine steroidogenic tissues. J. Steroid Biochem. Mol. Biol., 43: 805-826, 1992a.
Labrie, F., Simard, J., Luu-The, V., Bélanger, A., Pelletier, G., Morel, Y., Mebarki, F., Sanchez, R., Durocher, F., Turgeon, C., Labrie, Y., Rhéaume, E., Labrie, C., and Lachance, Y. The 3b-hydroxysteroid dehydrogenase/isomerase gene family: lessons from type II 3b-HSD congenital deficiency. In: Signal Transduction in Testicular Cells. Ernst Schering Research Foundation Workshop. Hansson, V., Levy, F.O. and Taskén, K. (eds.), Berlin, Heidelberg, New York, Springer-Verlag, Vol. Suppl. 2: pp. 185-218, 1996b.
Labrie, F., Sugimoto, Y., Luu-The, V., Simard, J., Lachance, Y., Bachvarov, D., Leblanc, G., Durocher, F., and Paquet, N. Structure of human type II 5a-reductase. Endocrinology, 131: 1571-1573, 1992c.
Mazess, R.B. On aging bone loss. Clin. Orthop., 165: 239-252, 1982.
Papanicolaou, G.N., and Shorr, E. The action of ovarian follicular hormones in the menopause, as indicated by vaginal smears. Am J Obstet Gynecol, 31: 806-831, 1936.
Selye, H., McEuen, C.s., and Collip, J.B. Effect of testosterone on the mammary gland. Proc. Soc. Exp. Biol., 34: 201, 1936.
Steinauer, J.E., Waetjen, L.E., Vittinghoff, E., Subak, L.L., Hulley, S.B., Grady, D., Lin, F., and Brown, J.S. Postmenopausal hormone therapy: does it cause incontinence? Obstet Gynecol, 106: 940-5, 2005.
Wied, G.L. Hormonal cytology. In: The manual of cytotechnology. Keebler, C.M. and Somrak, T.M. (eds.), Chicago, IL, American Society of Clinical Pathologists Press: pp. 62-72, 1993.
Women's Health Initiative. Risks and benefits of estrogen plus progestin in healthy postmenopausal women. JAMA, 288: 321-333, 2002.

ClinicalTrials.gov Identifier: NCT00429806     History of Changes
Other Study ID Numbers: ERC-213
Study First Received: January 31, 2007
Last Updated: January 31, 2007
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on September 11, 2014