Trials Sponsors Conditions Drugs Pricing

Conditions

Sleep disturbances associated with menopause

Outcome Measures

Primary Outcomes (1)

Change from baseline in WASO at Week 4 as measured by PSG

Secondary Outcomes (9)

Change from baseline in WASO at Week 12 as measured by PSG
Change from baseline in SE at Week 4 as measured by PSG
Change from baseline in SE at Week 12 as measured by PSG
Change from baseline in PROMIS SD SF 8b total score at Week 4
Change from baseline in PROMIS SD SF 8b total score at Week 12
+4 more secondary outcomes

Interventions

placebo of BAY 3427080Type not reported

BAY 3427080Type not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
BAY 3427080
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, SOFT
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

BAY 3427080
Named ingredient: elinzanetant
View registry record

Eligibility Criteria

Sexfemale

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Females aged 40 to 65 years, inclusive, at signing of informed consent.
Being in the post-menopausal period, defined as: serum FSH levels >40 mIU/mL and a serum estradiol concentration of <30 pg/mL at screening, and Hysterectomy performed at least 6 weeks prior to screening.

Sponsors & Collaborators

Bayer Consumer Care AG
Industrylead
Bayer AG
Industryco_sponsor

Study Sites (27)

Anima

Diepenbeek, 3590, Belgium

Erik Buntinx+3211949115 erik.buntinx@anima-alken.be

CHU Saint Pierre

Brussels, 1000, Belgium

Marie Bruyneel+3225354244 marie.bruyneel@stpierre-bru.be

UZ Leuven

Leuven, 3000, Belgium

Dries Testelmans+3216342522

Central Study Contacts

Therapeutic Area Head

+4930300139003 clinical-trials-contact@bayer.com

Therapeutic Area Head

+4930300139003

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

November 3, 2023

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2023-504955-28-01
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 03:42:49 UTC

Documents

D4_Patient facing document_Questionnaire_PROMIS_EN_public

A study to learn about how elinzanetant works and how safe it is in women having sleep disturbances associated with menopause

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (27)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (27)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations