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Be Part of Research - Trial Details - Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study I)
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Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study I)

Completed

Open to: FEMALE

Age: 40.0 - 65.0

Glasgow Corby Coventry High Wycombe London Northwood Romford Shipley Wokingham Orpington Orpington

Medical Conditions

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This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This is a two-part study designed to evaluate the effect of Estetrol (E4) 15 or 20 mg, or placebo on the severity and frequency of vasomotor symptoms (VMS) (Efficacy Study Part) and the safety of E4 20 mg (Endometrial and General Safety Study Part)

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2019 Feb 2024

Publications

"Gaspard U, Taziaux M, Jost M, Coelingh Bennink HJT, Utian WH, Lobo RA, Foidart JM. A multicenter, randomized, placebo-controlled study to select the minimum effective dose of estetrol in postmenopausal participants (E4Relief): part 2-vaginal cytology, genitourinary syndrome of menopause, and health-related quality of life. Menopause. 2023 May 1;30(5):480-489. doi: 10.1097/GME.0000000000002167. Epub 2023 Feb 20."; "36809193"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Estetrol oral tablet: administered orally once daily

Intervention Arm Group : Estetrol 15 mg - Efficacy Part;Estetrol 20 mg + P4 100 mg - Safety Part;Estetrol 20 mg - Efficacy Part;

Intervention Type : DRUG
Intervention Description : Placebo oral tablet: administered orally once daily

Intervention Arm Group : Placebo - Efficacy Part;

Intervention Type : DRUG
Intervention Description : Progesterone oral tablet: administered orally once daily

Intervention Arm Group : Estetrol 20 mg + P4 100 mg - Safety Part;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • CPS Research
    Glasgow
    G20 0XA
  • Accellacare - (MeDiNova Limited) - Northamptonshire
    Corby
    NN18 9EZ
  • Accellacare (Previously MeDiNova) Warwickshire Quality Research Site
    Coventry
    CV3 4FJ
  • Egin Research Ltd
    High Wycombe
    HP11 2QW
  • Queen Charlotte's and Chelsea Hospital - Imperial College Healthcare NHS Trust
    London
    W12 0NN
  • Accellacare - (MeDiNova Limited) - North London
    Northwood
    HA6 2RN
  • Accellacare - (MeDiNova Limited) - East London
    Romford
    RM1 3PJ
  • Accellacare - (MeDiNova Limited) - Yorkshire
    Shipley
    BD18 3SA
  • Accellacare - (MeDiNova Limited) - West London
    Wokingham
    RG40 1XS
  • Accellacare - South London
    Orpington
    BR5 3QG
  • Estetra Study Site
    Orpington
    BR5 3QG


The study is sponsored by Estetra and is in collaboration with ICON Clinical Research.



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Read full details for Trial ID: NCT04209543
Last updated 24 January 2025

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