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Hormone combo could boost diabetes control in menopause

NCT ID NCT06715514

Disease control Sponsor: Lia Bally Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 05, 2026 · Updated 3 times

Summary

This study looks at whether adding menopausal hormone therapy to a GLP-1 drug (semaglutide) improves blood sugar control in early postmenopausal women who have or are at risk for type 2 diabetes. About 96 women with menopausal symptoms and a BMI of 27 or higher will be enrolled. The main goal is to see if the combination works better than the GLP-1 drug alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Semaglutide (Wegovy) and menopausal hormone therapy (estradiol and micronized progesterone)
What this could lead to
If it works, this could point toward a more effective treatment for preventing or managing type 2 diabetes in early postmenopausal women.
What could go wrong
This is a small, early-phase study with only 96 participants, so results may not apply to everyone. The combination therapy may also have side effects like nausea or hormone-related risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 96 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Individuals fulfilling at enrolment all of the following inclusion criteria are eligible for the study: * Early postmenopausal status (STRAW+10 stage +1b or +1c and FSH\>25.0mU/L) * Presence of menopausal symptoms (total MRS-II score ≥1) * BMI ≥ 27.0kg/m2 * Pre- or existing type 2 diabetes (HbA1c 5.7%-8.5%) * No prior or current use of MHT The presence of any of the following exclusion criteria will lead to exclusion of the individuals: * DPP4-inhibitor, SLGT2-inhibitor or sulfonylurea use within 8 weeks prior to study enrolment * GLP-1RA use within 6 months prior to study enrolment * Insulin therapy within 8 weeks prior to study enrolment * History of bariatric surgery * More than 2% change in body weight within three months prior to study enrolment (based on documented or reported weights) * Contraindications for the use of the study medication as per prescription labelling: Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 * Known or suspected cancer of breast or other sexual organ, abnormal genital bleeding of unknown cause, hepatic neoplasia * Arterial or venous thromboembolic events, porphyria * Known allergy or hypersensitivity to Wegovy®, Estradot® or Utrogestan® (pharmaceutical agents or any of the excipients) * Systemic hormone therapy or hormonal contraceptives (e.g. estrogens, progestogens, androgens) during the study and within 12 months prior to participation * Herbal remedies and complimentary medicines for menopausal symptoms during the study * Physical or psychological condition or any medical intervention (including medication not specified above) likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator * Participation in another clinical trial that interferes with the interpretation of the study results * Inability to read German * Unwillingness to follow the study procedures

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Conditions

The condition(s) this trial relates to.

diabetes mellitus prediabetes syndrome type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Menopause Type 2 diabetes

Contacts and locations

Locations

  • University Hospital Bern

    Bern, 3010, Switzerland

More trials for these conditions

Other studies related to the condition(s) this trial covers.