Menopausal WomenPRO-MHTNCT07496294
Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy
A study testing Dydrogesterone 10 MG Oral Tablet, Micronized progesterone 200 MG and Transdermal estradiol in people with Menopausal Women and Menopausal Symptom Relief, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Menopausal Women, Menopausal Symptom Relief, Hormone Therapy
- What is being tested?
- Dydrogesterone 10 MG Oral Tablet, Micronized progesterone 200 MG and Transdermal estradiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
Istanbul, 34785
Esra Ayanoglu, MD, +90 544 544 62 42, dresraayanoglu@gmail.com
Sevil Cankaya, MD, +90 505 866 34 09, sevilsaltek82@gmail.com
About this study
Official title: Comparison of Oral Dydrogesterone and Vaginal Micronized Progesterone Regimens Combined With Transdermal Estradiol in Menopausal Hormone Therapy: A Prospective Randomized Controlled 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.
Read more
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.
Read the 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.
- Being tested
- Dydrogesterone 10 MG Oral Tablet, Micronized progesterone 200 MG, Transdermal estradiol
- Keywords
- Menopausal hormone therapy, Dydrogesterone, Micronized progesterone, Transdermal estradiol, Progesterone route of administration, Endometrial thickness, Postmenopausal women, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dydrogesterone 10 MG Oral TabletDrug
Also called Duphaston
Oral dydrogesterone will be administered in combination with transdermal estradiol as part of menopausal hormone therapy.
Micronized progesterone 200 MGDrug
Also called Progestan
Vaginal micronized progesterone will be administered in combination with transdermal estradiol as part of menopausal hormone therapy.
Transdermal estradiolDrug
Also called Femijel
Transdermal estradiol gel will be used as estrogen therapy in both treatment groups.
| Study group | Role | What they receive |
|---|---|---|
| Oral Dydrogesterone Group | Experimental | Participants will receive transdermal estradiol gel combined with oral dydrogesterone as the progesterone component of menopausal hormone therapy. Receives: Drug: Dydrogesterone 10 MG Oral Tablet; Drug: Transdermal estradiol |
| Vaginal Micronized Progesterone Group | Experimental | Participants will receive transdermal estradiol gel combined with vaginal micronized progesterone as the progesterone component of menopausal hormone therapy. Receives: Drug: Micronized progesterone 200 MG; Drug: Transdermal estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial Thickness
Endometrial thickness measured by transvaginal ultrasonography to evaluate endometrial safety during menopausal hormone therapy.
Measured: 12 months
Secondary outcomes (5)
Menopause-Specific Quality of Life (MENQOL) Score
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.
Measured: Baseline and 12 months
Vaginal Maturation Index
Assessment of vaginal epithelial maturation through cytological evaluation.
Measured: Baseline and 12 months
Vaginal Symptom Score (Visual Analog Scale, VAS)
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.
Measured: Baseline and 12 months
Vaginal pH
Measurement of vaginal pH as an indicator of vaginal health.
Measured: Baseline and 12 months
Number of bleeding and spotting days and proportion of participants with amenorrhea
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.
Measured: Throughout the 12-month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Menopausal WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to receive transdermal estradiol combined with either oral dydrogesterone or vaginal micronized progesterone.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esra Ayanoglu, Principal investigator, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496294
- Sponsor's protocol ID
- AYANOGLU-MHT-RCT-2026
- Acronym
- PRO-MHT
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional data protection policies and privacy considerations for study participants.
Publications
Graham S, Archer DF, Simon JA, Ohleth KM, Bernick B. Review of menopausal hormone therapy with estradiol and progesterone versus other estrogens and progestins. Gynecol Endocrinol. 2022 Nov;38(11):891-910. doi: 10.1080/09513590.2022.2118254. Epub 2022 Sep 8.
PubMed 36075250Hipolito Rodrigues MA, Gompel A. Micronized progesterone, progestins, and menopause hormone therapy. Women Health. 2021 Jan;61(1):3-14. doi: 10.1080/03630242.2020.1824956. Epub 2020 Sep 21.
PubMed 32957843
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oral Dydrogesterone and Vaginal Micronized Progesterone Regimens Combined With Transdermal Estradiol in Menopausal Hormone Therapy: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07496294
- Acronym / sponsor ID
- PRO-MHT / AYANOGLU-MHT-RCT-2026
- Keywords
- Menopausal hormone therapy, Dydrogesterone, Micronized progesterone, Transdermal estradiol, Progesterone route of administration, Endometrial thickness, Postmenopausal women, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to receive transdermal estradiol combined with either oral dydrogesterone or vaginal micronized progesterone.
| Arm | Type | Receives |
|---|---|---|
| Oral Dydrogesterone Group | Experimental | Drug: Dydrogesterone 10 MG Oral Tablet, Drug: Transdermal estradiolParticipants will receive transdermal estradiol gel combined with oral dydrogesterone as the progesterone component of menopausal hormone therapy. |
| Vaginal Micronized Progesterone Group | Experimental | Drug: Micronized progesterone 200 MG, Drug: Transdermal estradiolParticipants will receive transdermal estradiol gel combined with vaginal micronized progesterone as the progesterone component of menopausal hormone therapy. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dydrogesterone 10 MG Oral TabletAlso: DuphastonOral dydrogesterone will be administered in combination with transdermal estradiol as part of menopausal hormone therapy. | Drug | Oral Dydrogesterone Group |
| Micronized progesterone 200 MGAlso: ProgestanVaginal micronized progesterone will be administered in combination with transdermal estradiol as part of menopausal hormone therapy. | Drug | Vaginal Micronized Progesterone Group |
| Transdermal estradiolAlso: FemijelTransdermal estradiol gel will be used as estrogen therapy in both treatment groups. | Drug | Oral Dydrogesterone Group, Vaginal Micronized Progesterone Group |
Primary outcome
Endometrial Thickness
Time frame: 12 months
Endometrial thickness measured by transvaginal ultrasonography to evaluate endometrial safety during menopausal hormone therapy.
5 secondary outcomes
Menopause-Specific Quality of Life (MENQOL) Score
Time frame: Baseline and 12 months
Vaginal Maturation Index
Time frame: Baseline and 12 months
Vaginal Symptom Score (Visual Analog Scale, VAS)
Time frame: Baseline and 12 months
Vaginal pH
Time frame: Baseline and 12 months
Number of bleeding and spotting days and proportion of participants with amenorrhea
Time frame: Throughout the 12-month study period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 36075250Graham S, Archer DF, Simon JA, Ohleth KM, Bernick B. Review of menopausal hormone therapy with estradiol and progesterone versus other estrogens and progestins. Gynecol Endocrinol. 2022 Nov;38(11):891-910. doi: 10.1080/09513590.2022.2118254. Epub 2022 Sep 8.
- Background: PubMed 32957843Hipolito Rodrigues MA, Gompel A. Micronized progesterone, progestins, and menopause hormone therapy. Women Health. 2021 Jan;61(1):3-14. doi: 10.1080/03630242.2020.1824956. Epub 2020 Sep 21.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional data protection policies and privacy considerations for study participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Esra Ayanoglu principal investigator
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dydrogesterone 10 MG Oral Tablet, Micronized progesterone 200 MG and Transdermal estradiol in people with Menopausal Women and Menopausal Symptom Relief, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esra Ayanoglu, MD (+90 544 544 62 42, dresraayanoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial Thickness (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07496294, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.