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Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy

NCT07496294 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-27

No results posted yet for this study

Summary

Menopause is a natural stage in a woman's life that can be associated with symptoms such as hot flashes, night sweats, sleep problems, and vaginal dryness. Menopausal hormone therapy is commonly used to relieve these symptoms. In women with an intact uterus, progesterone must be used together with estrogen to protect the lining of the uterus.

The purpose of this study is to compare two commonly used progesterone treatment methods in women receiving menopausal hormone therapy. All participants will use transdermal estradiol gel, and they will be randomly assigned to receive either oral dydrogesterone or vaginal micronized progesterone.

This prospective randomized controlled study will evaluate the effects of these treatments on endometrial thickness, menopausal symptoms, vaginal health parameters, bleeding patterns, and quality of life over a 12-month follow-up period.

The results of this study may help determine the most appropriate progesterone regimen for women undergoing menopausal hormone therapy.

Conditions

  • Menopausal Women
  • Menopausal Symptom Relief
  • Hormone Therapy
  • Menopausal Hormone Therapy

Interventions

DRUG

Dydrogesterone 10 MG Oral Tablet

Oral dydrogesterone will be administered in combination with transdermal estradiol as part of menopausal hormone therapy.

DRUG

Micronized progesterone 200 MG

Vaginal micronized progesterone will be administered in combination with transdermal estradiol as part of menopausal hormone therapy.

DRUG

Transdermal estradiol

Transdermal estradiol gel will be used as estrogen therapy in both treatment groups.

Sponsors & Collaborators

  • Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

    lead OTHER

Principal Investigators

  • Esra Ayanoglu · Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-10-31
Completion
2027-10-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07496294 on ClinicalTrials.gov