COMPASS - COpenhagen MenoPAuSe Study
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age40-65
SponsorMartin Blomberg Jensen
About this trial
During menopause, estrogen levels drop while the level of another hormone - LH (luteinizing hormone) substantially increases. This hormonal shift is linked to bone Loss and other complications. Estrogen therapy can help, but some women avoid it due to the increased risk of blood clots and cancer. This project will investigate whether blocking LH could offer a safe alternative to alleviate symptoms and complications of menopause since it is known from previous research that high LH levels contribute to both bone deterioration and metabolic issues. The goal is to explore new treatment options that can improve health and quality of life for women both during and after menopause. This randomized clinical trial is a single center, sponsor-investigator-initiated single-blinded 8 weeks clinical trial with four parallel groups comparing the effect of an gonadotropin releasing hormone(GnRH)-analog with placebo, and with two additional arms given estrogen or testosterone on change on bone health in postmenopausal women with moderate-to-severe symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women >40 years and ≤65 at screening visit
A body mass index between 18-35
Confirmed menopause
Method 1
Disqualifiers
Current or previous hormone replacement therapy (HRT)
Vaginal estradiol/vaginal inserts (e.g. Vagifem®) can be used, but will have to be pause 2 weeks prior to randomization and throughout the study period
Menopausal Hormone Therapy (MHT) can be used by participants, but must be paused 6 weeks prior to inclusion.
Current or previous cancer diagnosis
Trial design
Design model
Parallel
Treatments tested in this trial
Triptorelin 11.25 mg
DrugPamorelin 11.25 mg intramuscular injection once
Sodium Chloride 0.9%
DrugSaline intramuscular injection once
Estradiol (E2)
DrugEstreva gel 1.5 mg daily
Testosterone
DrugTostran gel 10 mg every other day
Placebo gel
DrugPlacebo gel every day or every other day
Treatment groups
192 Participants
are divided into 4 treatment groupsGroup A: GnRH analogActive comparator 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions
Group C: Transdermal EstrogenActive comparator 2 interventions
Group D: Transdermal testosteroneActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
Change in bone remodeling from baseline to week 8.
Change in bone remodeling defined by change in bone marker (ΔCTX) from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1. GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2. Combined analysis of all 4 arms of the RCT 3. GnRH analog and estradiol 4. GnRH analog and testosterone 5. Estradiol and placebo 6. Testosterone and placebo 7. Estradiol and testosterone
Time frame
From baseline to week 82
Change in bone remodeling from baseline to week 8.
Change in bone remodeling defined by change in bone marker (ΔP1NP) from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone
Time frame
From baseline to week 83
Change in bone remodeling from baseline to week 8
Change in bone remodeling defined by change in bone marker-ratios (ΔCTX/ΔP1NP, and ΔBBI) from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone
Time frame
From baseline to week 8Secondary outcomes
1
Change in serum levels of Hypothalamic-Pituitary-Adrenal (HPA) axis from baseline to week 8
Change in serum levels of Hypothalamic-Pituitary-Adrenal (HPA) axis from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone
Time frame
Baseline to week 82
Change in serum levels of Hypothalamic-Pituitary-Gonadal (HPG) axis from baseline to week 8
Change in serum levels of Hypothalamic-Pituitary-Gonadal (HPG) axis from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone
Time frame
Baseline to week 83
Change in serum levels of Hypothalamic-Pituitary-Thyroid (HPT) axis from baseline to week 8
Change in serum levels of Hypothalamic-Pituitary-Thyroid (HPT) axis from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone
Time frame
Baseline to week 84
Change in quality of life evaluated with MENQOL-1 from baseline to week 8
Change in quality of life evaluated with The Menopause-specific Quality of Life (MENQOL) Questionnaire from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone. MENQOL is ranging from 0 (asymptomatic woman) to 232 (extremely bothered).
Time frame
Baseline to week 8Other outcomes
1
Change in fasting insulin from baseline to week 8
Change in fasting insulin from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone
Time frame
Baseline to week 82
Change in HbA1C from baseline to week 8
Change in HbA1C (mmol/mol) from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone
Time frame
Baseline to week 83
Change in HOMA-IR from baseline to week 8
Change in HOMA-IR from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone.
Time frame
Baseline to week 84
Change in total cholesterol, cholesterol (total, HDL, LDL), and triglycerides from baseline to week 4 and 8
Change in total cholesterol, cholesterol (total, HDL, LDL), and triglycerides from baseline to week 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone
Time frame
Baseline to week 4 and 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Martin Blomberg Jensen
Lead sponsor
Copenhagen University Hospital at Herlev
Sponsor institution
Source ClinicalTrials.gov