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

NCT02224313 | Completed Phase 3 Results DMC

• 1 other identifier: CRC-VgCy
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause

Keywords

vaginal cytokine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Vaginal Cytokines During Follow-up

  At 14 days and 28 days follow-up

Study Arms (2)

1.Premenopausal women

NO INTERVENTION

No treatment

2.Postmenopausal women with hormones

EXPERIMENTAL

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; Drug: oral progesterone 100 mg

Interventions

oral estradiol 1.0 mg DRUG

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

Also known as: Estrace

2.Postmenopausal women with hormones

oral progesterone 100 mg DRUG

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

Also known as: Prometrium

2.Postmenopausal women with hormones

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Intira Sriprasert: lead
• TherapeuticsMD: collaborator

Study Sites (1)

David Archer, MD

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Interventions

Estradiol; Progesterone

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnenediones; Pregnenes; Pregnanes; Corpus Luteum Hormones; Progesterone Congeners

Limitations and Caveats

Several limitations of this study were the small sample size and limited follow-up time, which limited the power to detect statistical significance in some outcomes.

Results Point of Contact

• Title: Dr.David Archer
• Organization: Eastern Virginia Medical School

archerdf@evms.edu

7574467444

Study Officials

• David F Archer, MD

  Eastern Virginia Medical School

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 30, 2014
• First Posted: August 25, 2014
• Study Start: December 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: March 19, 2020
• Results First Posted: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)