NCT05033886: Daylight

A Study of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause

Completed Phase 3 Last updated 26 October 2024

What this trial tests

Phase 3 trial testing fezolinetant in Vasomotor Symptoms in 453 participants. Completed in 20 April 2023.

Timeline

8 November 2021

Primary endpoint
27 March 2023

20 April 2023

Quick facts

Lead sponsor	Astellas Pharma Global Development, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	453
Start date	8 November 2021
Primary completion	27 March 2023
Estimated completion	20 April 2023
Sites	69 locations across Denmark, France, Finland, Italy, Netherlands, Belgium, Sweden, United Kingdom

Drugs / interventions tested

• fezolinetant (FEZOLINETANT) — full drug profile →
• placebo

Conditions studied

• Vasomotor Symptoms — all drugs for Vasomotor Symptoms →

Sponsor

Astellas Pharma Global Development, Inc. — full company profile →

Who can join

Adults 40 to 65, female only, with Vasomotor Symptoms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is for women in menopause who have moderate to severe hot flashes. It is for women who are unable to use hormone replacement therapy (HRT). Menopause, a normal part of life, is the time after a woman's last period. Hot flashes often occur during menopause. They can disrupt a woman's daily life.

The study medicines (also called investigational products, or IP) are tablets of fezolinetant or placebo. An investigational product means that the product is not yet licensed. In this study, a placebo is a dummy treatment that looks like fezolinetant but does not have any medicine in it. The study will compare fezolinetant with the placebo to learn if fezolinetant reduces the number and severity of hot flashes.

Women that want to take part in the study will be given an electronic handheld device with an app to track their hot flashes. Some women may be able to use the app on their own smartphone. In the last 10 days before their next clinic visit, the women will record information about their hot flashes. They can take part in the study if they have an average of 7 or more moderate to severe hot flashes each day. Women will be picked for 1 of 2 treatments (fezolinetant or placebo) by chance alone.

Women who take part in the study will take 2 tablets every day for 24 weeks. Treatment will be double-blinded. That means that the women in the study and the study doctors will not know who takes which of the study medicines (fezolinetant or placebo). The women will continue recording information about their hot flashes on the electronic device or their phone. They will also use another device to answer questions about how hot flashes affect their daily life.

During the study, the women will visit their study clinic several times for a check-up. This will happen during Weeks 2, 4, 8, 12, 16, 20, 24, and 27. Some women may be able to have home visits instead, from Week 2 to Week 20. At the check-up, they will be asked if they have any medical problems. Other checks will include vital signs (heart rate, temperature and blood pressure) and some blood samples taken for laboratory tests. At some check-ups, the women will have a physical exam. In Week 2 and Week 24, the women will have an ECG to check their heart rhythm. Women who have a uterus will also have a test called a transvaginal ultrasound. A probe is gently placed inside the vagina. Sound waves will create a picture of the organs in the pelvis. This will allow the study doctor to look more closely at the uterus and surrounding organs.

The last check-up (at Week 27) will be 3 weeks after they take their last tablets of study medicine (fezolinetant or placebo).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy and safety of fezolinetant for moderate-severe vasomotor symptoms associated with menopause in individuals unsuitable for hormone therapy: phase 3b randomised controlled trial.
   Schaudig K, Wang X, Bouchard C, Hirschberg AL, et al · · 2024 · cited 8× · PMID 39557487 · DOI 10.1136/bmj-2024-079525
2. Management of menopausal hot flushes. Recommendations from the Spanish Menopause Society.
   Fasero M, Sanchez M, Baquedano L, Gippini I, et al · · 2025 · cited 4× · PMID 39944633 · DOI 10.1016/j.eurox.2025.100366
3. Fezolinetant treatment for hot flashes associated with menopause: A plain language summary of the DAYLIGHT study.
   Shapiro M, Nappi RE, Wang X, Morga A, et al · · 2026 · PMID 41930718 · DOI 10.1177/17455057261432619
4. Estimated impact of fezolinetant versus placebo on work productivity and indirect costs among women experiencing vasomotor symptoms associated with menopause.
   Morga A, Tai TA, Kapoor R, Song W, et al · · 2026 · PMID 41915440 · DOI 10.1097/gme.0000000000002755
5. PERCEIVE: A retrospective, qualitative interview-based study of the impact of vasomotor symptoms associated with menopause on the lives of individuals who are not suitable candidates for hormone therapy.
   Hirschberg AL, Morga A, Bruon F, Martins K, et al · · 2025 · PMID 40752049 · DOI 10.1016/j.maturitas.2025.108670
6. Treating moderate to severe menopausal vasomotor symptoms with fezolinetant: responder analysis of the phase 3b DAYLIGHT study
   Shapiro M, Schaudig K, Hirschberg A, Blogg M, et al · · 2025
7. 5092 Effect of Fezolinetant Treatment on Patient-Reported Outcomes: Data from Phase 3b study (DAYLIGHT) for Moderate-To-Severe Vasomotor Symptoms Associated with Menopause in Women Considered Unsuitable for Hormone Therapy
   · 2024