Evaluation of triptorelin, estradiol, and testosterone compared to placebo for changes in bone markers in postmenopausal women

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What is this study about?

This study focuses on women experiencing menopause, a natural process when menstrual periods permanently stop. The research aims to compare the effects of different treatments on bone health in postmenopausal women. The treatments being tested include triptorelin (a hormone-regulating medication given as an injection), estradiol (a female hormone applied as a gel on the skin), testosterone (a hormone also applied as a gel on the skin), and placebo.

The study involves four different groups of participants, with each group receiving one of the treatments mentioned above. The medications are administered over an 8-week period. Triptorelin is given as an injection into the muscle, while both estradiol and testosterone are applied to the skin as gels. Some participants will receive placebo treatment instead of active medication.

During the study, researchers will monitor changes in bone health markers and other body functions. The study will also track changes in various aspects of participants’ health, including hormone levels, quality of life, sleep patterns, and other health indicators. Regular check-ups and blood tests will be performed to ensure participant safety throughout the study period.

1 Initial treatment assignment

You will be randomly assigned to one of four treatment groups for an 8-week study period

The treatment options include: GnRH-analog injection, transdermal estrogen gel, transdermal testosterone gel, or placebo gel

2 Baseline measurements

Initial measurements will be taken including blood tests, weight, and heart rhythm (ECG)

You will complete several questionnaires about your symptoms and quality of life

A small tissue sample from abdominal fat will be collected

A spinal fluid sample will be taken

3 Treatment period – Week 1-4

If assigned to the injection group: receive Pamorelin (triptorelin) as a single muscle injection

If assigned to gel groups: apply prescribed gel (estrogen, testosterone, or placebo) to skin daily

Week 4: Blood and urine tests will be performed to check hormone levels and other health indicators

4 Treatment period – Week 5-8

Continue with assigned treatment

Record any changes in menopausal symptoms

Week 8: Final tests including blood work, urine tests, weight measurement, and heart rhythm check

Complete final set of questionnaires about symptoms and quality of life

Final tissue sample from abdominal fat will be collected

Final spinal fluid sample will be taken

5 Study completion

Treatment ends after 8 weeks

All test results will be reviewed to evaluate changes in bone markers and other health indicators

Who Can Join the Study?

Must be a woman between 40 and 65 years old at the time of screening
Must have a body mass index (BMI) between 18 and 35 (BMI is a measure of body fat based on height and weight)
Must be in confirmed menopause (permanent cessation of menstrual periods)
Must experience moderate to severe vasomotor symptoms (hot flashes and night sweats that significantly affect daily life)

Who Cannot Join the Study?

Age below 18 or above 65 years
Male participants (study is for females only)
Currently taking hormone replacement therapy (medications that contain female hormones)
History of breast cancer or other hormone-dependent cancers
Presence of osteoporosis (a condition causing bones to become weak and brittle)
Current use of medications that affect bone metabolism
Not being in postmenopausal state (women who still have menstrual periods)
Having any severe medical conditions that could interfere with the study
History of blood clotting disorders
Liver disease or abnormal liver function
Uncontrolled hypertension (high blood pressure)
Participation in another clinical trial within the past 30 days
Known allergies to any of the study medications
Current smoking habit
Body Mass Index (BMI) above 35 (severe obesity)

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Hsbaks Hcpsiade	Herlev	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	01.08.2025

Trial locations

Investigated drugs:

Gonadotropin-releasing hormone (GnRH) analog
This medication helps control hormone levels in the body. It works by affecting the release of reproductive hormones. In this study, it’s being used to understand its effects on bone health in women after menopause.

Transdermal estrogen
This is a hormone therapy that’s applied to the skin, allowing estrogen to be absorbed into the bloodstream. Estrogen is a natural hormone that decreases during menopause. The study examines how this treatment affects bone markers in postmenopausal women.

Transdermal testosterone
This is also a hormone therapy applied through the skin. Testosterone, while typically thought of as a male hormone, is also present in women in smaller amounts. The study investigates how this treatment impacts bone health markers in postmenopausal women.

Investigated diseases:

Menopause

Menopause – A natural biological process marking the end of a woman’s reproductive years, typically occurring between ages 45 and 55. During menopause, the ovaries gradually decrease their production of estrogen and progesterone hormones. This transition period can last several years and is characterized by changes in menstrual cycles, eventually leading to their complete cessation. The process involves various physical changes in the body, including effects on bone density, body temperature regulation, and metabolism. Physical symptoms may include hot flashes, night sweats, and changes in bone metabolism.

Note: Based on the trial data provided, this is the only medical condition explicitly mentioned that requires description according to the given format and guidelines.

Trial ID:

2025-522558-37-00

Trial Phase:

Therapeutic exploratory (Phase II)

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