Effect of Oral Estradiol and Progesterone Therapy on Vaginal Cytokines in Postmenopausal Women
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|ClinicalTrials.gov Identifier: NCT02224313|
Recruitment Status : Completed
First Posted : August 25, 2014
Last Update Posted : January 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Menopause||Drug: oral estradiol 1.0 mg Drug: oral progesterone 100 mg||Phase 3|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Effect of Oral Estradiol and Progesterone Therapy on Vaginal Cytokines in Postmenopausal Women|
|Actual Study Start Date :||December 2015|
|Actual Primary Completion Date :||August 2018|
|Actual Study Completion Date :||August 2018|
No Intervention: 1.Premenopausal women
Experimental: 2.Postmenopausal women with hormones
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
one tablet of oral estradiol 1.0 mg once a day for 28 days
Other Name: Estrace
Drug: oral progesterone 100 mg
one tablet of oral progesterone 100 mg once a day for 14 days
Other Name: Prometrium
- baseline vaginal cytokines [ Time Frame: 1 month ]Determine the differences in vaginal cytokines Il-1β and IL-8 between premenopausal and postmenopausal women.
- vaginal cytokines changes [ Time Frame: 1 month ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224313
|United States, Virginia|
|David Archer, MD|
|Norfolk, Virginia, United States, 23507|
|Study Director:||David F Archer, MD||Eastern Virginia Medical School|