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 26 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
- EUCTR2020-004908-33-HU
- Lead Sponsor
- Bayer Consumer Care AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 370
1. Females aged 40 to 65 years, inclusive, at signing of informed consent.
1. 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 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.
2. 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, vital signs, gynecological ultrasound, endometrial biopsy, mammogram, clinical laboratory tests, eC-SSRS, BDI 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.
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 Hot Flash Daily Diary (HFDD) for at least 11 days during the two weeks preceding baseline visit, and participant has recorded at least 50 moderate or severe HF (including night-time HF) over the last 7 days that the HFDD was completed (assessed at the Baseline Visit).
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 363
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7
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 exclusion criteria 9).
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 previous history of any malignancy (except basal and squamous cell skin tumors).
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. A history of untreated hyperthyroidism or hypothyroidism. 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 bleeding.
8. Clinically relevant abnormal findings on mammogram.
9. Renal impairment greater than moderate (i.e. estimated glomerular filtration rate < 30 mL/min) 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 onset of efficacy of elinzanetant for the treatment of VMS associated with the menopause.<br>2. To evaluate the efficacy of elinzanetant in women treated for relief of VMS associated with the menopause on: sleep quality; menopause related quality of life; depressive symptoms.<br>3. To evaluate the safety of elinzanetant for the treatment of VMS associated with the menopause.;Primary end point(s): 1. Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD]).<br>2. Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD).;Timepoint(s) of evaluation of this end point: 1. Baseline to Week 4.<br>2. Baseline to Week 12.
- Secondary Outcome Measures
Name Time Method