Beneficial Effects of Oral Premarin Estrogen Replacement Therapy Assessed by Human Genome Array

NCT00318318 | Completed Phase 1

• 2 other identifiers: R-06-710GR12198E
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the immunological status of patients using Premarin. Premarin use is associated with an enhanced immune status, and possibly even some anti-cancer effect. The researchers will compare the use of Premarin with those not using hormone replacement therapy (HRT) to track the effects of Premarin in reducing the risk of infection and swelling.

Conditions

Healthy; Estrogen Replacement Therapy

Keywords

Premarin,; HRT,; RNA,; Gene Expression.; Postmenopausal Women

Outcome Measures

Primary Outcomes (1)

• Human genome array

Secondary Outcomes (1)

• Denaturing gradient gel electrophoresis

Interventions

Premarin DRUG

Eligibility Criteria

• Age: 35 Years - 95 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women taking oral Premarin at least for the last month with no urogenital anatomical abnormalities.
• Women not taking HRT for at least one month with no urogenital anatomical abnormalities (controls).

You may not qualify if:

• Males.
• Subjects who are not menopausal.
• Less than 35 years of age.
• Subjects with recurrent sexually transmitted disease.
• Subjects with abnormal renal function (serum creatinine \>110umol/l, upper limit 90umol/l) or pyelonephritis.
• Subjects receiving prednisone or immunosuppressive drugs,
• Subjects who need to be treated for any urogenital infection or with any antimicrobial therapy.
• Personal history of known or suspected estrogen-dependent neoplasia such as breast or endometrial cancer.
• Undiagnosed abnormal vaginal bleeding.
• Active hepatic dysfunction or disease, especially of the obstructive type.
• Active thrombophlebitis, thrombosis or thromboembolic disorders.
• Endometrial hyperplasia.
• Subjects on anticoagulants, antidiabetic and antihypertensive agents

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Lawson Health Research Institute

London, Ontario, N6A 4V2, Canada

Location

Related Publications (16)

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• Wiesenfeld HC, Hillier SL, Krohn MA, Landers DV, Sweet RL. Bacterial vaginosis is a strong predictor of Neisseria gonorrhoeae and Chlamydia trachomatis infection. Clin Infect Dis. 2003 Mar 1;36(5):663-8. doi: 10.1086/367658. Epub 2003 Feb 7.

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• Cherpes TL, Meyn LA, Krohn MA, Hillier SL. Risk factors for infection with herpes simplex virus type 2: role of smoking, douching, uncircumcised males, and vaginal flora. Sex Transm Dis. 2003 May;30(5):405-10. doi: 10.1097/00007435-200305000-00006.

  PMID: 12916131 BACKGROUND

• Devillard E, Burton JP, Hammond JA, Lam D, Reid G. Novel insight into the vaginal microflora in postmenopausal women under hormone replacement therapy as analyzed by PCR-denaturing gradient gel electrophoresis. Eur J Obstet Gynecol Reprod Biol. 2004 Nov 10;117(1):76-81. doi: 10.1016/j.ejogrb.2004.02.001.

  PMID: 15474249 BACKGROUND

• Burton JP, Reid G. Evaluation of the bacterial vaginal flora of 20 postmenopausal women by direct (Nugent score) and molecular (polymerase chain reaction and denaturing gradient gel electrophoresis) techniques. J Infect Dis. 2002 Dec 15;186(12):1770-80. doi: 10.1086/345761. Epub 2002 Nov 22.

  PMID: 12447763 BACKGROUND

• Heinemann C, Reid G. Vaginal microbial diversity among postmenopausal women with and without hormone replacement therapy. Can J Microbiol. 2005 Sep;51(9):777-81. doi: 10.1139/w05-070.

  PMID: 16391657 BACKGROUND

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• Habis AH, Vernon SD, Lee DR, Verma M, Unger ER. Molecular quality of exfoliated cervical cells: implications for molecular epidemiology and biomarker discovery. Cancer Epidemiol Biomarkers Prev. 2004 Mar;13(3):492-6.

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• Chen B, Wen Y, Zhang Z, Guo Y, Warrington JA, Polan ML. Microarray analysis of differentially expressed genes in vaginal tissues from women with stress urinary incontinence compared with asymptomatic women. Hum Reprod. 2006 Jan;21(1):22-9. doi: 10.1093/humrep/dei276. Epub 2005 Aug 26.

  PMID: 16126751 BACKGROUND

• Dahn A, Saunders S, Hammond JA, Carter D, Kirjavainen P, Anukam K, Reid G. Effect of bacterial vaginosis, Lactobacillus and Premarin estrogen replacement therapy on vaginal gene expression changes. Microbes Infect. 2008 May;10(6):620-7. doi: 10.1016/j.micinf.2008.02.007. Epub 2008 Feb 21.

  PMID: 18485781 DERIVED

MeSH Terms

Interventions

Estrogens, Conjugated (USP)

Intervention Hierarchy (Ancestors)

Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Gregor Reid, PhD, MBA

  Lawson Health Research Institute and The University of Western Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 24, 2006
• First Posted: April 26, 2006
• Study Start: March 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: February 1, 2007
• Last Updated: July 9, 2009

Record last verified: 2009-07

Locations

CA (1)