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

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ClinicalTrials.gov Identifier: NCT02224313
Recruitment Status : Unknown
Verified August 2016 by Intira Sriprasert, Eastern Virginia Medical School.
Recruitment status was:  Recruiting
First Posted : August 25, 2014
Last Update Posted : August 4, 2016
Sponsor:
Collaborator:
TherapeuticsMD
Information provided by (Responsible Party):
Intira Sriprasert, Eastern Virginia Medical School

Brief 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.

Condition or disease Intervention/treatment Phase
Menopause Drug: oral estradiol 0.5 mg Drug: oral estradiol 1.0 mg Drug: oral progesterone 100 mg Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
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
Study Start Date : December 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : August 2017


Arm Intervention/treatment
No Intervention: 1.Premenopausal women
No treatment
Experimental: 2.Postmenopausal women with hormones
Oral hormone therapy will be given to women in this group. Daily dose of oral "estradiol" 0.5 mg will be given the first 14 days after enrollment. Then a daily dose of oral "estradiol" 0.5 mg and "progesterone" 100 mg for 14 days will be given during the following 14 days.
Drug: oral estradiol 0.5 mg
Other Name: Estrace

Drug: oral progesterone 100 mg
Other Name: Prometrium

Experimental: 3.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
Other Name: Estrace

Drug: oral progesterone 100 mg
Other Name: Prometrium




Primary Outcome Measures :
  1. baseline vaginal cytokines [ Time Frame: 1 month ]
    Determine the differences in vaginal cytokines Il-1β, Il-6 and IL-8 between premenopausal and postmenopausal women.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 65 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 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

Information from the National Library of Medicine

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


Contacts
Contact: JULIA CAUL 757.446.7977 cauljd@evms.edu

Locations
United States, Virginia
David Archer, MD Recruiting
Norfolk, Virginia, United States, 23507
Contact: JULIA CAUL    757-446-7977      
Sub-Investigator: Intira Sriprasert, MD         
Sub-Investigator: Tarita Pakrashi, MD, MPH         
Principal Investigator: David Archer, MD         
Sponsors and Collaborators
Intira Sriprasert
TherapeuticsMD
Investigators
Study Director: David F Archer, MD Eastern Virginia Medical School

Responsible Party: Intira Sriprasert, Dr., Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT02224313     History of Changes
Other Study ID Numbers: CRC-VgCy
First Posted: August 25, 2014    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Intira Sriprasert, Eastern Virginia Medical School:
vaginal cytokine

Additional relevant MeSH terms:
Hormones
Estradiol
Polyestradiol phosphate
Progesterone
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogens
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Progestins