Menopausal Women, Menopausal Symptom Relief, Hormone Therapy, Menopausal Hormone Therapy
Conditions
Keywords
Menopausal hormone therapy, Dydrogesterone, Micronized progesterone, Transdermal estradiol, Progesterone route of administration, Endometrial thickness, Postmenopausal women, Randomized controlled trial
Brief 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.
Detailed description
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.
Interventions
Oral dydrogesterone will be administered in combination with transdermal estradiol as part of menopausal hormone therapy.
Vaginal micronized progesterone will be administered in combination with transdermal estradiol as part of menopausal hormone therapy.
Transdermal estradiol gel will be used as estrogen therapy in both treatment groups.
Sponsors
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The study is open-label and participants will receive one of the two progesterone regimens according to randomization.
Intervention model description
Participants will be randomly assigned to receive transdermal estradiol combined with either oral dydrogesterone or vaginal micronized progesterone.
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endometrial Thickness | 12 months | Endometrial thickness measured by transvaginal ultrasonography to evaluate endometrial safety during menopausal hormone therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Menopause-Specific Quality of Life (MENQOL) Score | 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. |
| Vaginal Maturation Index | Baseline and 12 months | Assessment of vaginal epithelial maturation through cytological evaluation. |
| Vaginal Symptom Score (Visual Analog Scale, VAS) | 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. |
| Vaginal pH | Baseline and 12 months | Measurement of vaginal pH as an indicator of vaginal health. |
| Number of bleeding and spotting days and proportion of participants with amenorrhea | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTEsra Ayanoglu, MD
CONTACTSevil Cankaya, MD
PRINCIPAL_INVESTIGATOREsra Ayanoglu
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Outcome results
None listed