Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-60
SponsorSehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Women aged 45-60 years

Postmenopausal status (absence of menstruation for ≥12 months)

Intact uterus

Presence of menopausal symptoms requiring menopausal hormone therapy

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Dydrogesterone 10 MG Oral Tablet
  • Micronized progesterone 200 MG
  • Transdermal estradiol

Treatment groups

200 Participants
are divided into 2 treatment groups