Assessment of the treatment of vasomotor symptoms during 26 weeks in postmenopausal women. In addition, there will be checked if improvement is noticed in sleep quality, menopausal related quality of life and depressive symptoms.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
vasomotorische symptomen in de menopauze
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mean change in frequency of moderate to severe hot flash (HF) from baseline to
Week 4 (assessed by hot flash daily diary [HFDD])
Mean change in frequency of moderate to severe HF from baseline to Week 12
(assessed by HFDD)
Mean change in severity of moderate to severe HF from baseline to Week 4
(assessed by HFDD)
Mean change in severity of moderate to severe HF from baseline to Week 12
(assessed by HFDD)
Secondary outcome
Mean change in frequency of moderate to severe HF from baseline to Week 1
(assessed by HFDD)
Mean change in frequency of moderate to severe HF from baseline over time
Mean change in patient-reported outcomes measurement information system sleep
disturbance short form 8b (PROMIS SD SF 8b) total score from baseline to Week 12
Mean change in menopause specific quality of life scale (MENQOL) total score
from baseline to Week 12
Mean change in Beck depression inventory (BDI-II) total score from baseline to
Week 12
Mean change in BDI-II total score from baseline to Week 26
Background summary
Researchers are looking for a better way to treat women who have hot flashes
after they have been through the menopause. Hot flashes are caused by the
hormonal changes that happen when a woman*s body has been through the
menopause. Menopause is when women stop having a menstrual cycle, also called a
period. During the period, the ovaries increasingly produce less sex hormones
as a result of the natural ageing process and related hormonal adjustments. The
decline in hormone production can lead to various symptoms which, in some
cases, can have a very adverse effect on a menopausal woman's quality of life.
The study treatment, BAY 3427080, was designed to treat symptoms caused by
hormonal changes. It works by blocking a protein called neurokinin from sending
signals to other parts of the body, which is thought to play a role in starting
hot flashes. There are treatments for hot flashes in women who have been
through the menopause, but may cause medical problems for some people.
In this study, the researchers will learn how well BAY 3427080 works compared
to a placebo in women who have been through the menopause and have hot flashes.
A placebo looks like a treatment but does not have any medicine in it. To
compare these study treatments, the doctors will ask the participants to record
information about their hot flashes in an electronic diary. The researchers
will study the number of hot flashes the participants have and how severe they
are. They will look at the results from before treatment, after 4 weeks, and
after 12 weeks of treatment.
Study objective
Assessment of the treatment of vasomotor symptoms during 26 weeks in
postmenopausal women. In addition, there will be checked if improvement is
noticed in sleep quality, menopausal related quality of life and depressive
symptoms.
Study design
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 women.
Study duration: about 30 weeks
Screening Period: 2-4 weeks (plus washout period if applicable)
Treatment duration: 26 weeks
Follow-up period for safety
Intervention
Experimental: BAY 3427080, 120 mg daily oral administration as tablet.
Placebo: Placebo daily, placebo match for BAY 3427080 oral administration as
tablet.
After randomization, each participant will receive BAY 3427080 or placebo
orally daily for 12 weeks followed by a 14 week period during which both groups
(BAY 3427080 and placebo group) will receive BAY 3427080 orally daily as
tablet.
Study burden and risks
NA
Siriusdreef 36
Hoofddorp 2130AB
NL
Siriusdreef 36
Hoofddorp 2130AB
NL
Listed location countries
Age
Inclusion criteria
- 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)
Exclusion criteria
- 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-004908-33-NL |
| CCMO | NL78392.100.21 |