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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 10 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 assigned the intervention described below. • Oral estradiol 1.0 mg tablet for 14 days, then oral estradiol 1.0 mg tablet and progesterone 100 mg capsule for 14 days

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

Conditions
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Menopause

Intervention / Treatment
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* Drug: oral estradiol 1.0 mg
* Drug: oral progesterone 100 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premenopausal and Postmenopausal women: Female between the ages of 20 and 40 years (premenopausal arm), OR be a female between the ages of 45 and 65 years (postmenopausal arm) willing to participate in the study, as documented by signing the informed consent form. Postmenopausal women with an intact uterus and at least 12 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). No oral hormone therapy for 8 weeks and transdermal or vaginal hormone therapy for 4 week prior to the study. Willing to use oral hormone therapy during the study period (postmenopausal women only). Willing to abstain from using products (other than study medication) that contain estrogen, progestin, or progesterone throughout study participation. Have general good health. Willing to refrain from sexual intercourse for 48 hours before vaginal sample collection. 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 Be allergic to estrogen or progesterone products Have active genital infection or inflammation based on vaginal wet preparation, power of hydrogen (pH), whiff test and potassium hydroxide (KOH) preparation 2.1 Vulvovaginal candidiasis, trichomonas vaginitis or bacterial vaginitis 2.2 Sexually transmitted diseases including herpes simplex viral infection, gonorrhea and Chlamydia Have a known contraindication for oral hormone therapy or allergy to use of estradiol and/or progesterone 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 Have used tamoxifen, raloxifene or other selective estrogen receptor modulators (SERMs) therapy within 8 weeks prior to screening Have used an intrauterine device (IUD) within 8 weeks prior to screening Have used vaginal products (pessary, tampon, tablets, douching) within 7 days prior to screening Have evidence of cervical, vaginal, or vulvar intraepithelial neoplasia or cancer Have a past or current history breast cancer, endometrial cancer or endometrial hyperplasia, hypertriglyceridemia or venous thromboembolism Be an immuno-compromised patient including those with human immunodeficiency viral infection, chronic glucocorticoid use or active treatment with immunosuppressive agents Have a history of or current evidence of thromboembolism Have evidence of uncontrolled Hypertension Blood pressure >140/100 mmHg Have confirmed Diabetes Mellitus Currently smoking For sexually active premenopausal women, should be protected against pregnancy by sterilization, condom use, abstinence, or same sex relationship

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1.Premenopausal women<br>No treatment | |
| Experimental: 2.Postmenopausal women with hormones<br>Oral hormone therapy will be given to women in this group. Daily dose of oral estradiol 1 mg will be given the first 14 days after enrollment. Then a daily dose of oral estradiol 1 mg and progesterone 100 mg for 14 days will be given during the following 14 days. | Drug: oral estradiol 1.0 mg<br>* one tablet of oral estradiol 1.0 mg once a day for 28 days<br>* Other names: Estrace;Drug: oral progesterone 100 mg<br>* one tablet of oral progesterone 100 mg once a day for 14 days<br>* Other names: Prometrium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal Cytokines at Baseline | Determine the differences in vaginal cytokines: interleukin (IL)-1β and IL-8 between premenopausal and postmenopausal women. | At baseline visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal Cytokines During Follow-up | Determine the changes in vaginal cytokines in postmenopausal women following treatment with estradiol then estradiol and progesterone compared to the normal menstrual cycle changes in young premenopausal women. | At 14 days and 28 days follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginal cytokine