A study to learn more about how well elinzanetant works and how safe it is for the treatment of vasomotor symptoms (hot flashes) that are caused by hormonal changes over 52 weeks in women who have been through the menopause.
- Conditions
- Vasomotor symptoms associated with menopauseMedDRA version: 21.1Level: LLTClassification code 10050903Term: Postmenopausal symptomsSystem Organ Class: 100000004872Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2021-000059-38-FI
- Lead Sponsor
- Bayer Consumer Care AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 600
1. Females aged 40 to 65 years, inclusive, at signing of informed consent.
2. Postmenopausal, defined as:
a. at least 12 months of spontaneous amenorrhea prior to signing of informed consent, or
b. at least 6 months of spontaneous amenorrhea prior to signing of informed consent with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL and a serum estradiol concentration of < 30 pg/mL, or
c. at least 6 months after hysterectomy at signing of informed consent with serum FSH levels > 40 mIU/mL^2 and a serum estradiol concentration of < 30 pg/mL, or
d. surgical bilateral oophorectomy with or without hysterectomy at least 6 weeks prior to signing of informed consent.
3. Moderate to severe hot flash (HF) associated with the menopause and seeking treatment for this condition.
4. Negative urine pregnancy test at Screening.
5. In good general health, in the opinion of the investigator, based on the medical history, physical examination, 12-lead ECG, BMD, vital signs, gynecological ultrasound, endometrial biopsy, mammogram, clinical laboratory tests, eC-SSRS, and other assessments completed during screening.
6. Normal or clinically insignificant cervical cytology not requiring further follow-up:
a. A cervical cytology sample has to be obtained during screening, or
b. A documented normal result has to be available from cervical cytology conducted within 12 months prior to signing of informed consent.
c. HPV testing in participants with ASCUS will be used as an adjunctive test automatically. Participants with ASCUS can be included if they are negative for high-risk HPV strains.
d. HPV testing in participants with absence of
endocervical/transformation zone component will be used as an adjunctive test automatically. Participants can be included if they are negative for high-risk HPV strains.
7. BMI between 18 and 38 kg/m2 at screening
8. Participant has a screening mammogram performed, unless she is able to provide a written normal mammogram result obtained no more than 6 months prior to the start of screening.
9. Participant has completed HFDD for at least 11 days during the two weeks preceding baseline visit and is showing eligibility with respect to inclusion criterion 3 during this time period.
10. Capable of giving signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 588
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12
1. Any clinically significant prior or ongoing history of arrhythmias, heart block and QT prolongation either determined through clinical history or on ECG evaluation.
2. Any clinically significant abnormal laboratory test result(s) measured during screening (single re-test allowed, except for tests listed in inclusion criteria 2 and exclusion criteria 10).
3. Any active ongoing condition that could cause difficulty in interpreting vasomotor symptoms (VMS) such as: infection that could cause pyrexia, pheochromocytoma, carcinoid syndrome.
4. Current or history (except complete remission for 5 years or more) of any malignancy (except basal and squamous cell skin tumors). Women receiving adjuvant endocrine therapy (e.g. tamoxifen, aromatase inhibitors, GnRH analogues) cannot be enrolled in this study.
5. Uncontrolled or treatment-resistant hypertension. Women with mild hypertension can be included in the study if they are medically cleared prior to study participation.
6. Untreated hyperthyroidism or hypothyroidism. Treated hyperthyroidism with no abnormal increase of thyroid function laboratory parameters and no relevant clinical signs for > 6 months before signing of informed consent is acceptable. Treated hypothyroidism with normal thyroid function test results during screening and a stable (for > 3 months before signing of informed consent) dose of replacement therapy is acceptable.
7. Any unexplained post-menopausal uterine bleeding.
8. Clinically relevant abnormal findings on mammogram.
9. Renal impairment greater than moderate (i.e. estimated glomerular filtration rate
< 30 mL/min/ 1.73m2) at screening
10. Abnormal liver parameters.
11. Disordered proliferative endometrium, endometrial hyperplasia, polyp, or endometrial cancer diagnosed based on endometrial biopsy during screening.
12. Any other history, condition, therapy, or uncontrolled intercurrent illness which could in the opinion of the investigator affect compliance with study requirements.
13. Has used and is unwilling to wash-out use of any of the prohibited concomitant medications.
14. Inability to comply with the use of prohibited medications.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of elinzanetant for the treatment of vasomotor symptoms (VMS) associated with the menopause.;Secondary Objective: 1. To evaluate the efficacy of elinzanetant on: sleep quality; menopause related quality of life; weight and body composition in women being treated for relief of VMS associated with the menopause.<br>2. To evaluate the safety of elinzanetant for the treatment of VMS associated with the menopause.;Primary end point(s): Mean change in frequency of moderate to severe hot flashes (HFs) from baseline to Week 12 (assessed by hot flash daily diary [HFDD]).;Timepoint(s) of evaluation of this end point: Baseline to Week 12.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score from baseline over time.<br>2. Mean change in menopause specific quality of life scale (MENQOL) total score from baseline over time.;Timepoint(s) of evaluation of this end point: 1. Baseline to Week 56.<br>2. Baseline to Week 56.