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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

4 criteria

  • 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 trial?

15 criteria

  • 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)
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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.

What is already known about the treatment

Based on the provided trial data, I'll describe the relevant medications: GnRH analog - A synthetic hormone medication administered via injection that mimics the natural gonadotropin-releasing hormone in the body. This medication works by regulating the production of reproductive hormones and is commonly used in treating various hormonal conditions, including menopausal symptoms. It functions by binding to specific receptors in the pituitary gland, affecting the release of luteinizing hormone and follicle-stimulating hormone, and belongs to the class of hormone-modulating agents. Transdermal estrogen - A hormone replacement therapy delivered through the skin via patches or gels, designed to supplement declining estrogen levels during menopause. This medication is absorbed directly into the bloodstream through the skin, bypassing the digestive system, and helps manage various menopausal symptoms while potentially protecting bone density. It belongs to the class of hormone replacement medications and works by maintaining estrogen levels in the body. Transdermal testosterone - A hormone therapy applied to the skin in the form of patches, gels, or creams, used to supplement testosterone levels in postmenopausal women. This medication is absorbed through the skin directly into the bloodstream and may help improve bone density, energy levels, and other menopausal symptoms. It belongs to the androgen class of hormones and works by maintaining testosterone levels in the body.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522558-37-00Estimated enrolment200 patientsSponsorRegion Hovedstaden

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