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NCT Number: NCT07496294

Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy

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.

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Key information

Conditions

Menopausal Women Hormone Therapy Menopausal Hormone Therapy Menopausal Symptom Relief

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Menopausal hormone therapy (MHT) is widely used for the treatment of vasomotor symptoms and genitourinary symptoms associated with menopause. In women with an intact uterus, progestogens must be administered together with estrogen therapy to prevent endometrial hyperplasia. Different progesterone formulations and routes of administration are available, including oral and vaginal preparations. However, comparative data regarding the clinical effects and endometrial safety of different progesterone regimens combined with transdermal estradiol are limited.

This prospective randomized controlled trial aims to compare two commonly used progesterone regimens in women receiving menopausal hormone therapy. All participants will receive transdermal estradiol gel and will be randomly assigned to one of two treatment groups: oral dydrogesterone or vaginal micronized progesterone. The study will follow participants for approximately 12 months.

The primary outcome of the study is endometrial thickness measured by transvaginal ultrasonography. Secondary outcomes include menopausal symptoms, quality of life assessed by validated questionnaires, vaginal health parameters such as vaginal maturation index and vaginal pH, bleeding patterns recorded in bleeding diaries, carotid intima-media thickness, and bone mineral density measurements.

The findings of this study are expected to contribute to the identification of the most appropriate progesterone regimen for women undergoing menopausal hormone therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 45-60 years
  • Postmenopausal status (absence of menstruation for ≥12 months)
  • Intact uterus
  • Presence of menopausal symptoms requiring menopausal hormone therapy
  • Willingness to participate and provide written informed consent

Exclusion criteria

  • Unexplained vaginal bleeding
  • History of breast cancer or endometrial cancer
  • Known hypersensitivity to study medications
  • History of thromboembolic disease (e.g., deep vein thrombosis or pulmonary embolism)
  • Severe liver disease
  • Uncontrolled hypertension
  • Any condition that, in the opinion of the investigator, makes participation inappropriate

Treatment and study plan

Dydrogesterone 10 MG Oral Tablet

Drug

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

Other names: Duphaston

Micronized progesterone 200 MG

Drug

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

Other names: Progestan

Transdermal Estradiol

Drug

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

Other names: Femijel

Primary outcomes

  1. Endometrial Thickness

    Time frame: 12 months

    Endometrial thickness measured by transvaginal ultrasonography to evaluate endometrial safety during menopausal hormone therapy.

Secondary outcomes

  1. Menopause-Specific Quality of Life (MENQOL) Score

    Time frame: Baseline and 12 months

    Change in menopause-related quality of life assessed using the Menopause-Specific Quality of Life (MENQOL) questionnaire. The MENQOL is a 29-item questionnaire with scores ranging from 1 to 8 for each item, where higher scores indicate worse menopausal symptoms and lower quality of life.

  2. Vaginal Maturation Index

    Time frame: Baseline and 12 months

    Assessment of vaginal epithelial maturation through cytological evaluation.

  3. Vaginal Symptom Score (Visual Analog Scale, VAS)

    Time frame: Baseline and 12 months

    Severity of vaginal symptoms including dryness, irritation, and dyspareunia measured using a Visual Analog Scale (VAS). The VAS ranges from 0 to 10, where 0 indicates no symptoms and 10 indicates the most severe symptoms. Higher scores indicate worse symptom severity.

  4. Vaginal pH

    Time frame: Baseline and 12 months

    Measurement of vaginal pH as an indicator of vaginal health.

  5. Number of bleeding and spotting days and proportion of participants with amenorrhea

    Time frame: Throughout the 12-month study period

    Bleeding patterns will be evaluated using participant-recorded daily bleeding diaries. The number of bleeding and spotting days will be calculated, and the proportion of participants achieving amenorrhea will be determined.

Other outcomes

  1. Carotid Intima-Media Thickness

    Time frame: Baseline and 12 months

    Assessment of carotid artery intima-media thickness using ultrasound.

  2. Bone Mineral Density

    Time frame: Baseline and 12 months

    Bone mineral density measured using dual-energy X-ray absorptiometry (DEXA).

Study contacts

Contact information is provided by the study sponsor or research team.

Esra Ayanoglu, MD

CONTACT

[email protected]

+90 544 544 62 42

Sevil Cankaya, MD

CONTACT

[email protected]

+90 505 866 34 09

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Comparison of Oral Dydrogesterone and Vaginal Micronized Progesterone Regimens Combined With Transdermal Estradiol in Menopausal Hormone Therapy: A Prospective Randomized Controlled Trial

Acronym: PRO-MHT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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