Hop extract vs soy isoflavone for menopausal symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized, double-blind, head-to-head trial, 120 women aged 45–60 with moderate to severe menopausal symptoms take one daily capsule of hop extract or soy isoflavone extract for 12 weeks. The primary outcome is change in the psychological domain of the Menopause Rating Scale from baseline to week 12. Secondary outcomes include other MRS domains, anxiety, depressive symptoms, quality of life, body composition, and safety, with assessments at baseline, week 6, and week 12. All participants, investigators, and data analysts are masked to treatment allocation; an emergency unblinding procedure is available if needed.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Woman aged 45 to 60 years (both inclusive).
* Perimenopausal or postmenopausal status according to the Stages of Reproductive Aging Workshop +10 (STRAW+10) criteria.
* Moderate to severe menopausal symptoms, defined as a total Menopause Rating Scale (MRS) score of 15 or higher at the baseline assessment prior to randomization.
* Not receiving menopausal hormone therapy (MHT) and not having received it in the previous 3 months.
* Ability to understand and complete the study questionnaires autonomously.
* Written informed consent.

Exclusion Criteria:

* Known allergy or hypersensitivity to soy or any of its derivatives.
* Known allergy or hypersensitivity to hops or to other species of the Cannabaceae family.
* Personal history of breast cancer, endometrial cancer or any other hormone-dependent tumor.
* Genital bleeding of undiagnosed cause.
* Current use, or use in the previous 3 months, of MHT, tibolone, selective estrogen receptor modulators, or dietary supplements or products specifically intended for menopausal symptoms or with a relevant phytoestrogen content, or anticipated need to start any of them during the study.
* Current treatment with antidepressants, anxiolytics, hypnotics, gabapentin or pregabalin.
* Known liver disease or abnormal baseline liver profile (transaminases more than twice the upper limit of normal).
* Moderate or severe renal insufficiency.
* History of venous thromboembolic disease.
* Oral anticoagulant treatment.
* Body mass index (BMI) of 35 kg/m2 or higher.
* Pacemaker or any other implantable electronic device (contraindication for bioimpedance).
* Unstabilized major psychiatric disorder.
* Risky alcohol consumption or substance dependence.
* Simultaneous participation in another clinical trial or intervention study, or participation in one within the previous 30 days.
* Pregnancy or lactation.

Where it's running

• Menoclínica by Palacios
  Madrid, Madrid, Spain Recruiting

Study contacts

• Principal investigator: Silvia Pilar González Rodríguez — Menoclínica by Palacios
• Study coordinator: Esmeralda Josa
• Email: esmeralda.josa@menoclinica.com
• Phone: +34 914 324 499

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.