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

NCT ID: NCT02224313

Last Updated: 2020-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2018-08-31

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.

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 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

Conditions

Menopause

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

1.Premenopausal women

No treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

oral estradiol 1.0 mg

Intervention Type: DRUG

one tablet of oral estradiol 1.0 mg once a day for 28 days

oral progesterone 100 mg

Intervention Type: DRUG

one tablet of oral progesterone 100 mg once a day for 14 days

Interventions

oral estradiol 1.0 mg

one tablet of oral estradiol 1.0 mg once a day for 28 days

Intervention Type: DRUG

oral progesterone 100 mg

one tablet of oral progesterone 100 mg once a day for 14 days

Intervention Type: DRUG

Other Intervention Names

Estrace; Prometrium

Eligibility 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, 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

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

TherapeuticsMD

INDUSTRY

Sponsor Role: collaborator

Intira Sriprasert

OTHER

Sponsor Role: lead

Responsible Party

Intira Sriprasert

Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David F Archer, MD

Role: STUDY_DIRECTOR

Eastern Virginia Medical School

Locations

David Archer, MD

Norfolk, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CRC-VgCy

Identifier Type: -

Identifier Source: org_study_id