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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bayer Consumer Care AG, Bayer AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Trial duration

14 Mar 2024 → 8 Nov 2024

Decision date (initial)

2024-03-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Bayer Consumer Care AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacokinetic, Safety

To explore the efficacy of elinzanetant on sleep disturbances associated with menopause as determined by PSG

Secondary objectives 2

1. To explore the efficacy of elinzanetant on sleep disturbance associated with menopause as determined by patient reported outcomes
2. To evaluate the safety of elinzanetant for the treatment of sleep disturbances associated with menopause

Conditions and MedDRA coding

Sleep disturbances associated with menopause

Study design 1 period

Regulatory references

Plan to share IPD

No

IPD plan description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Females aged 40 to 65 years, inclusive, at signing of informed consent.
2. 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.
3. The participant’s self-reported sleep history includes ongoing sleep disturbances associated with menopause characterized by waking up at night and/or poor quality of sleep.
4. WASO of 30 minutes or more (mean of 2 screening PSGs with neither of the 2 nights <20 min).

Exclusion criteria 4

1. Medical history, or baseline PSG assessment, includes a diagnosis of a sleep disorder other than sleep disturbances associated with the menopause (e.g., sleep apnea, restless leg syndrome, circadian rhythm sleep disorder).
2. Current or history (except complete remission for 5 years or more) of any malignancy (except basal and squamous cell skin tumors).
3. Renal impairment greater than moderate (i.e. estimated glomerular filtration rate <30 mL/min/1.73 m^2) at screening
4. Abnormal liver parameters (presence of at least one of the following criteria): - AST >2 x ULN - ALT >2 x ULN - AP >2 x ULN - TBL >ULN unless explained by Gilbert’s syndrome - INR >ULN unless explained by, e.g., intake of anticoagulants - Diagnosis of hepatitis B infection, i.e., Hbs-antigen positive at screening - Diagnosis of hepatitis C infection, i.e., hepatitis C-antibodies and HCV-RNA positive at screening.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 9

1. Change from baseline in WASO at Week 12 as measured by PSG
2. Change from baseline in SE at Week 4 as measured by PSG
3. Change from baseline in SE at Week 12 as measured by PSG
4. Change from baseline in PROMIS SD SF 8b total score at Week 4
5. Change from baseline in PROMIS SD SF 8b total score at Week 12
6. Change from baseline in ISI total score at Week 4
7. Change from baseline in ISI total score at Week 12
8. TEAEs
9. Abnormal laboratory parameters

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bayer Consumer Care AG

Sponsor organisation

Bayer Consumer Care AG

Address

Peter Merian-Strasse 84

City

Basel

Postcode

4052

Country

Switzerland

Scientific contact point

Organisation

Bayer AG

Contact name

Therapeutic Area Head

Public contact point

Organisation

Bayer AG

Contact name

Therapeutic Area Head

Third parties 5

Bayer AG

Sponsor organisation

Bayer AG

Address

Kaiser-Wilhelm-Allee 1, Wiesdorf Wiesdorf

City

Leverkusen

Postcode

51373

Country

Germany

Scientific contact point

Organisation

Bayer AG

Contact name

Therapeutic Area Head

Public contact point

Organisation

Bayer AG

Contact name

Therapeutic Area Head

Sponsor responsibilities

Article 77 compliance

Bayer Consumer Care AG

Article 77 implementation

Bayer Consumer Care AG

Locations

7 EU/EEA countries · 27 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 20 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications