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Effect of Oral Estradiol and Progesterone Therapy on Vaginal Cytokines in Postmenopausal Women

Information source: Eastern Virginia Medical School
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Menopause

Intervention: oral estradiol 0.5 mg (Drug); oral estradiol 1.0 mg (Drug); oral progesterone 100 mg (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Intira Sriprasert

Official(s) and/or principal investigator(s):
David F Archer, MD, Study Director, Affiliation: Eastern Virginia Medical School

Overall contact:
JULIA CAUL, Phone: 757.446.7977, Email: cauljd@evms.edu

Summary

The purpose of this study is to compare the vaginal health between premenopausal and postmenopausal women before and after using oral "estradiol" for 14 days then "estradiol" and "progesterone" for 14 days.

Clinical Details

Official title: Effect of Oral Estradiol and Progesterone Therapy on Vaginal Cytokines in Postmenopausal Women

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: baseline vaginal cytokines

Secondary outcome: vaginal cytokines changes

Detailed description: This research project recruits 10 healthy, premenopausal women (aged 20-40 years-old) with regular menstrual cycle with interval of 24-35 days and duration of 2-7 days and 20 healthy postmenopausal women (aged 45-60 years-old) with an intact uterus and at least 12 months but not more than 36 months of spontaneous amenorrhea. Premenopausal women will not receive any study medication(s). Postmenopausal women will be "randomized" into one of the study groups described below.

- Oral "estradiol" 0. 5 mg tablet for 14 days, then oral "estradiol" 0. 5 mg tablet and

"progesterone" 100 mg capsule for 14 days

- Oral "estradiol" 1. 0 mg tablet for 14 days, then oral "estradiol" 1. 0 mg tablet and

"progesterone" 100 mg capsule for 14 days

Eligibility

Minimum age: 20 Years. Maximum age: 60 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Premenopausal and Postmenopausal women:

1. Female between the ages of 20 and 40 years (premenopausal arm), OR be a female between the ages of 45 and 60 years (postmenopausal arm) willing to participate in the study, as documented by signing the informed consent form. 2. Postmenopausal women with an intact uterus and at least 12 months but not more than 36 months of spontaneous amenorrhea (postmenopausal arm), OR be a premenopausal women with regular menstrual cycle with interval of 24-35 days and duration of 2-7 days (premenopausal arm). 3. No oral hormone therapy for 8 weeks and transdermal or vaginal hormone therapy for 4 week prior to the study. 4. Willing to use oral hormone therapy during the study period (postmenopausal women only). 5. Willing to abstain from using products (other than study medication) that contain estrogen, progestin, or progesterone throughout study participation. 6. Have general good health. 7. Willing to refrain from sexual intercourse for 48 hours before vaginal sample collection. 8. Willing to abstain from use of vaginal product 7 days before vaginal sample collection. Exclusion Criteria:

- To participate in the study, a subject must NOT

1. Be allergic to estrogen or progesterone products 2. Have active genital infection or inflammation based on vaginal wet preparation, pH, whiff test and KOH, preparation 2. 1 Vulvovaginal candidiasis, trichomonas vaginitis or bacterial vaginitis 2. 2 Sexually transmitted diseases including herpes simplex viral infection, gonorrhea and Chlamydia 3. Have a known contraindication for oral hormone therapy or allergy to use of estradiol and/or progesterone 4. Have used estrogen alone or estrogen/progestin for any of the following time periods: 4. 1 Vaginal hormone products (ring, cream, gels) within 30 days prior to screening 4. 2 Transdermal estrogen alone or estrogen/progestin products within 4 weeks prior to screening 4. 3 Oral estrogen and/or progestin therapy within 8 weeks prior to screening 4. 4 Progestational implants, estrogen or estrogen/progestational injectable drug therapy within 3 months prior to screening 4. 5 Estrogen pellet therapy or progestational injectable drug therapy within 6 months prior to screening 4. 6 Percutaneous estrogen lotions/gels within 4 weeks prior to screening 5. Have used tamoxifen, raloxifene or other selective estrogen receptor modulators (SERMs) therapy within 8 weeks prior to screening 6. Have used an intrauterine device (IUD) within 8 weeks prior to screening 7. Have used vaginal products (pessary, tampon, tablets, douching) within 7 days prior to screening 8. Have evidence of cervical, vaginal, or vulvar intraepithelial neoplasia or cancer 9. Have a past or current history breast cancer, endometrial cancer or endometrial hyperplasia, hypertriglyceridemia or venous thromboembolism 10. Be an immuno-compromised patient including those with human immunodeficiency viral infection, chronic glucocorticoid use or active treatment with immunosuppressive agents 11. Have a history of or current evidence of thromboembolism 12. Have evidence of uncontrolled Hypertension Blood pressure >140/100 mmHg 13. Have confirmed Diabetes Mellitus 14. Currently smoking 15. For sexually active premenopausal women, should be protected against pregnancy by sterilization, condom use, abstinence, or same sex relationship

Locations and Contacts

JULIA CAUL, Phone: 757.446.7977, Email: cauljd@evms.edu

David Archer, MD, Norfolk, Virginia 23507, United States; Not yet recruiting
JULIA CAUL, Phone: 757-446-7977
Intira Sriprasert, MD, Sub-Investigator
Tarita Pakrashi, MD, MPH, Sub-Investigator
David Archer, MD, Principal Investigator
Additional Information

Starting date: October 2015
Last updated: August 10, 2015

Page last updated: August 23, 2015

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