A double-blind, randomized, placebo-controlled multicenter study to investigate efficacy and safety of elinzanetant for the treatment of vasomotor symptoms over 26 weeks in postmenopausal wome
- Conditions
- vasomotorische symptomen in de menopauzeHot flushesmenopausal symptoms
- Registration Number
- NL-OMON54109
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 22
- 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.
- Moderate to severe hot flash (HF) associated with the menopause and seeking
treatment for this condition.
- 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)
- Any clinically significant prior or ongoing history of arrhythmias, heart
block and QT prolongation either determined through clinical history or on ECG
evaluation.
- Any active ongoing condition that could cause difficulty in interpreting
vasomotor symptoms (VMS) such as: infection that could cause pyrexia,
pheochromocytoma, carcinoid syndrome.
- Current or previous history of any malignancy (except basal and squamous cell
skin tumors).
- Uncontrolled or treatment-resistant hypertension. Women with mild
hypertension can be included in the study if they are medically cleared prior
to study participation.
- 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.
- Any unexplained post-menopausal bleeding.
- Clinically relevant abnormal findings on mammogram.
- Abnormal liver parameters.
- Disordered proliferative endometrium, endometrial hyperplasia, polyp, or
endometrial cancer diagnosed based on endometrial biopsy during screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Mean change in frequency of moderate to severe hot flash (HF) from baseline to<br /><br>Week 4 (assessed by hot flash daily diary [HFDD])<br /><br>Mean change in frequency of moderate to severe HF from baseline to Week 12<br /><br>(assessed by HFDD)<br /><br>Mean change in severity of moderate to severe HF from baseline to Week 4<br /><br>(assessed by HFDD)<br /><br>Mean change in severity of moderate to severe HF from baseline to Week 12<br /><br>(assessed by HFDD)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Mean change in frequency of moderate to severe HF from baseline to Week 1<br /><br>(assessed by HFDD)<br /><br>Mean change in frequency of moderate to severe HF from baseline over time<br /><br>Mean change in patient-reported outcomes measurement information system sleep<br /><br>disturbance short form 8b (PROMIS SD SF 8b) total score from baseline to Week 12<br /><br>Mean change in menopause specific quality of life scale (MENQOL) total score<br /><br>from baseline to Week 12<br /><br>Mean change in Beck depression inventory (BDI-II) total score from baseline to<br /><br>Week 12<br /><br>Mean change in BDI-II total score from baseline to Week 26</p><br>