MenopauseHOPESNCT07904390
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
A study testing Full Spectrum hop extract (MENODUO FullSpectrum) and Soy isoflavone extract in people with Menopause and Perimenopause, run by Menoclinica by Palacios at 1 site in Spain.
Trial summary
HOPES (Hops On Psychological and Estrogenic Symptoms in Menopause) is a randomized, double-blind, active-controlled nutritional intervention study in 120 peri- and postmenopausal women aged 45 to 60 years with moderate to severe menopausal symptoms. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Menopause, Perimenopause, Postmenopause
- What is being tested?
- Full Spectrum hop extract (MENODUO FullSpectrum) and Soy isoflavone extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 26 Oct 2026to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Menoclínica by Palacios
Madrid, Madrid, 28009
About this study
Official title: Efficacy of a Full Spectrum Hop (Humulus Lupulus L.) Extract Versus a Soy Extract in Women With Menopausal Symptoms: A Randomized, Double-Blind, Active-Controlled Nutritional Intervention Study (HOPES: Hops On Psychological and Estrogenic Symptoms in Menopause)
HOPES (Hops On Psychological and Estrogenic Symptoms in Menopause) is a randomized, double-blind, active-controlled nutritional intervention study in 120 peri- and postmenopausal women aged 45 to 60 years with moderate to severe menopausal symptoms. For 12 weeks, participants take one capsule per day of either a full spectrum hop (Humulus lupulus L.) extract or a soy isoflavone extract. Both products are marketed dietary supplements, and there is no placebo arm.
The main question is whether the hop extract, which combines prenylated flavonoids with bitter acids, improves the psychological symptoms of menopause (depressive mood, irritability, anxiety, and physical and mental exhaustion) more than the soy extract. The main outcome is the change in the psychological subscale of the Menopause Rating Scale (MRS) from baseline to week 12.
Secondary outcomes include the other MRS domains, anxiety, depressive symptoms, menopause-related quality of life, body composition, and safety.
Read the detailed description
Rationale
Many women cannot or do not wish to use menopausal hormone therapy (MHT) and turn to plant-based supplements. Soy isoflavones act mainly through estrogenic mechanisms and have shown a modest effect on vasomotor symptoms, while the evidence for psychological symptoms and sleep is more limited and less consistent. Hop extract has a dual profile: prenylated flavonoids, linked to estrogenic activity, and bitter acids, described in relation to GABAergic neurotransmission and vagal signalling. No direct comparison of the two extracts is available. HOPES tests whether this profile gives the hop extract a differential effect on the psychological domain of menopausal symptoms.
Design
Candidates complete a secure online screening (visit 0). Eligible women attend a baseline visit (visit 1) at the coordinating center, where eligibility is confirmed, assessments and a blood sample are taken, and participants are randomized 1:1 (computer-generated permuted blocks of variable size, stratified by center and menopausal status: perimenopause or postmenopause). Follow-up includes a visit at week 6 (visit 2, in person or remote) and a final visit at week 12 (visit 3).
Capsules and bottles are identical and coded by the sponsor. Participants, the research team and the statistician remain masked until database lock, and an emergency unblinding procedure is available. Adherence is assessed with a capsule diary and a count of returned product, and dietary intake with a 3-day food record at visits 1 and 3.
Assessments
Menopause Rating Scale (MRS), Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), Cervantes-31 quality of life scale, and 0-10 visual analogue scales (VAS) for hot flashes, sleep quality and mood; body composition by bioimpedance; and blood tests (liver profile, lipid profile, estradiol and follicle-stimulating hormone) at baseline and week 12.
Analysis
The primary outcome is analyzed in the intention-to-treat population with a mixed model for repeated measures. With 60 participants per arm, the study has 80% power, at a two-sided significance level of 5%, to detect a standardized effect size of about 0.52. Secondary outcomes are tested hierarchically.
A between-group difference of at least 0.5 standard deviations in the change of the MRS psychological subscale is prespecified as clinically relevant.
- Conditions
- Menopause, Perimenopause, Postmenopause
- Being tested
- Full Spectrum hop extract (MENODUO FullSpectrum), Soy isoflavone extract
- Keywords
- Humulus lupulus, hops, soy isoflavones, phytoestrogens, Menopause Rating Scale, dietary supplement, psychological symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Spectrum hop extract (MENODUO FullSpectrum)Dietary supplement
Also called MENODUO FullSpectrum
100 mg/day orally, one capsule per day for 12 weeks. Provides 10 mg/day of bitter acids and derivatives, 3.5 mg/day of prenylated flavonoids and 2.5 mg/day of xanthohumol.
Soy isoflavone extractDietary supplement
Description: 100 mg/day orally, one capsule per day for 12 weeks. Standardized to at least 40% total isoflavones (at least 40 mg/day) and at least 20% genistein (at least 20 mg/day).
| Study group | Role | What they receive |
|---|---|---|
| Hop extract | Experimental | One capsule per day for 12 weeks of MENODUO FullSpectrum, a dry hop (Humulus lupulus L.) strobilus extract, 100 mg/day, providing 10 mg/day of bitter acids and derivatives, 3.5 mg/day of prenylated flavonoids and 2.5 mg/day of xanthohumol. Receives: Dietary Supplement: Full Spectrum hop extract (MENODUO FullSpectrum) |
| Soy extract | Active comparator | One capsule per day for 12 weeks of a dry soy (Glycine max (L.) Merr.) seed extract, 100 mg/day, standardized to at least 40% total isoflavones (at least 40 mg/day) and selected to provide at least 20 mg/day of genistein. Receives: Dietary Supplement: Soy isoflavone extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the psychological subscale score of the Menopause Rating Scale (MRS)
The MRS psychological subscale is the sum of items 4 to 7 (depressive mood, irritability, anxiety, and physical and mental exhaustion), each rated from 0 (none) to 4 (very severe). Score range 0 to 16; higher scores indicate greater symptom severity. Change is the week 12 score minus the baseline score.
Measured: Baseline (visit 1) and week 12 (visit 3)
Secondary outcomes (15)
Change in total MRS score
Sum of the 11 MRS items, each rated 0 to 4. Score range 0 to 44; higher scores indicate greater severity.
Measured: Baseline, week 6 and week 12
Change in MRS somatic-vegetative subscale score
Sum of items 1, 2, 3 and 11. Score range 0 to 16; higher scores indicate greater severity.
Measured: Baseline, week 6 and week 12
Change in MRS urogenital subscale score
Sum of items 8, 9 and 10. Score range 0 to 12; higher scores indicate greater severity.
Measured: Baseline, week 6 and week 12
Change in Generalized Anxiety Disorder-7 (GAD-7) score
Seven items rated 0 to 3. Score range 0 to 21; higher scores indicate more anxiety symptoms.
Measured: Baseline and week 12 (optional at week 6)
Change in Patient Health Questionnaire-9 (PHQ-9) score
Nine items rated 0 to 3. Score range 0 to 27; higher scores indicate more depressive symptoms.
Measured: Baseline and week 12 (optional at week 6)
Change in the Cervantes Scale global score
The Cervantes Scale is a 31-item, menopause-specific health-related quality of life questionnaire. Each item is rated from 0 to 5. The global score ranges from 0 to 155; higher scores indicate worse health-related quality of life. Change is the week 12 score minus the baseline score.
Measured: Baseline and week 12
Change in the Cervantes Scale sexuality domain score
The sexuality domain of the Cervantes Scale (31-item, menopause-specific health-related quality of life questionnaire) comprises 4 items on sexual function, each rated from 0 to 5. The domain score ranges from 0 to 20; higher scores indicate worse sexual function. Change is the week 12 score minus the baseline score.
Measured: Baseline and week 12
Change in body fat percentage
Body fat percentage measured by bioimpedance.
Measured: Baseline and week 12
Change in estimated visceral fat
Visceral fat estimate measured by bioimpedance.
Measured: Baseline and week 12
Change in hot flash intensity (visual analogue scale)
0-10 scale; 0 = no hot flashes, 10 = maximum imaginable intensity.
Measured: Baseline, week 6 and week 12
Change in sleep quality (visual analogue scale)
0-10 scale; 0 = very poor sleep quality, 10 = excellent sleep quality.
Measured: Baseline, week 6 and week 12
Change in mood (visual analogue scale)
0-10 scale; 0 = very poor mood, 10 = excellent mood.
Measured: Baseline, week 6 and week 12
Number of participants with adverse events
Incidence, nature, severity, duration and relationship to the intervention, including events that lead to interruption of the intervention or withdrawal.
Measured: From baseline to week 12
Change in liver profile
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase and bilirubin.
Measured: Baseline and week 12
Change in lean mass
Lean mass in kilograms measured by bioimpedance.
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start26 Oct 2026
- Primary completion5 Feb 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoclinica by Palacios
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Pilar González Rodríguez, Menoclinica by Palacios
- Investigators
- Silvia Pilar González Rodríguez, Principal investigator, Menoclínica by Palacios
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904390
- Sponsor's protocol ID
- HOPES-2026-01
- Other IDs
- 6554
- Acronym
- HOPES
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared at this stage. Aggregate results will be published in a peer-reviewed journal.
Publications
Palacios S, Ferrer-Barriendos J, Parrilla JJ, Castelo-Branco C, Manubens M, Alberich X, Marti A; Grupo Cervantes. [Health-related quality of life in the Spanish women through and beyond menopause. Development and validation of the Cervantes Scale]. Med Clin (Barc). 2004 Feb 21;122(6):205-11. doi: 10.1016/s0025-7753(04)74198-6. Spanish.
PubMed 15012887Heinemann K, Ruebig A, Potthoff P, Schneider HP, Strelow F, Heinemann LA, Do MT. The Menopause Rating Scale (MRS) scale: a methodological review. Health Qual Life Outcomes. 2004 Sep 2;2:45. doi: 10.1186/1477-7525-2-45.
PubMed 15345062Morimoto-Kobayashi Y, Ohara K, Ashigai H, Kanaya T, Koizumi K, Manabe F, Kaneko Y, Taniguchi Y, Katayama M, Kowatari Y, Kondo S. Matured hop extract reduces body fat in healthy overweight humans: a randomized, double-blind, placebo-controlled parallel group study. Nutr J. 2016 Mar 9;15:25. doi: 10.1186/s12937-016-0144-2.
PubMed 26960416Keiler AM, Zierau O, Kretzschmar G. Hop extracts and hop substances in treatment of menopausal complaints. Planta Med. 2013 May;79(7):576-9. doi: 10.1055/s-0032-1328330. Epub 2013 Mar 19.
PubMed 23512496
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Full Spectrum Hop (Humulus Lupulus L.) Extract Versus a Soy Extract in Women With Menopausal Symptoms: A Randomized, Double-Blind, Active-Controlled Nutritional Intervention Study (HOPES: Hops On Psychological and Estrogenic Symptoms in Menopause)
- ClinicalTrials.gov ID
- NCT07904390
- Acronym / sponsor ID
- HOPES / HOPES-2026-01
- Conditions
- Menopause, Perimenopause, Postmenopause
- Keywords
- Humulus lupulus, hops, soy isoflavones, phytoestrogens, Menopause Rating Scale, dietary supplement, psychological symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Menoclinica by PalaciosUniversity, hospital or other
- Study start
- 26 Oct 2026 (actual)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HOPES (Hops On Psychological and Estrogenic Symptoms in Menopause) is a randomized, double-blind, active-controlled nutritional intervention study in 120 peri- and postmenopausal women aged 45 to 60 years with moderate to severe menopausal symptoms. For 12 weeks, participants take one capsule per day of either a full spectrum hop (Humulus lupulus L.) extract or a soy isoflavone extract. Both products are marketed dietary supplements, and there is no placebo arm.
The main question is whether the hop extract, which combines prenylated flavonoids with bitter acids, improves the psychological symptoms of menopause (depressive mood, irritability, anxiety, and physical and mental exhaustion) more than the soy extract. The main outcome is the change in the psychological subscale of the Menopause Rating Scale (MRS) from baseline to week 12.
Secondary outcomes include the other MRS domains, anxiety, depressive symptoms, menopause-related quality of life, body composition, and safety.
Detailed description
Rationale
Many women cannot or do not wish to use menopausal hormone therapy (MHT) and turn to plant-based supplements. Soy isoflavones act mainly through estrogenic mechanisms and have shown a modest effect on vasomotor symptoms, while the evidence for psychological symptoms and sleep is more limited and less consistent. Hop extract has a dual profile: prenylated flavonoids, linked to estrogenic activity, and bitter acids, described in relation to GABAergic neurotransmission and vagal signalling. No direct comparison of the two extracts is available. HOPES tests whether this profile gives the hop extract a differential effect on the psychological domain of menopausal symptoms.
Design
Candidates complete a secure online screening (visit 0). Eligible women attend a baseline visit (visit 1) at the coordinating center, where eligibility is confirmed, assessments and a blood sample are taken, and participants are randomized 1:1 (computer-generated permuted blocks of variable size, stratified by center and menopausal status: perimenopause or postmenopause). Follow-up includes a visit at week 6 (visit 2, in person or remote) and a final visit at week 12 (visit 3).
Capsules and bottles are identical and coded by the sponsor. Participants, the research team and the statistician remain masked until database lock, and an emergency unblinding procedure is available. Adherence is assessed with a capsule diary and a count of returned product, and dietary intake with a 3-day food record at visits 1 and 3.
Assessments
Menopause Rating Scale (MRS), Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), Cervantes-31 quality of life scale, and 0-10 visual analogue scales (VAS) for hot flashes, sleep quality and mood; body composition by bioimpedance; and blood tests (liver profile, lipid profile, estradiol and follicle-stimulating hormone) at baseline and week 12.
Analysis
The primary outcome is analyzed in the intention-to-treat population with a mixed model for repeated measures. With 60 participants per arm, the study has 80% power, at a two-sided significance level of 5%, to detect a standardized effect size of about 0.52. Secondary outcomes are tested hierarchically.
A between-group difference of at least 0.5 standard deviations in the change of the MRS psychological subscale is prespecified as clinically relevant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hop extract | Experimental | Dietary Supplement: Full Spectrum hop extract (MENODUO FullSpectrum)One capsule per day for 12 weeks of MENODUO FullSpectrum, a dry hop (Humulus lupulus L.) strobilus extract, 100 mg/day, providing 10 mg/day of bitter acids and derivatives, 3.5 mg/day of prenylated flavonoids and 2.5 mg/day of xanthohumol. |
| Soy extract | Active comparator | Dietary Supplement: Soy isoflavone extractOne capsule per day for 12 weeks of a dry soy (Glycine max (L.) Merr.) seed extract, 100 mg/day, standardized to at least 40% total isoflavones (at least 40 mg/day) and selected to provide at least 20 mg/day of genistein. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full Spectrum hop extract (MENODUO FullSpectrum)Also: MENODUO FullSpectrum100 mg/day orally, one capsule per day for 12 weeks. Provides 10 mg/day of bitter acids and derivatives, 3.5 mg/day of prenylated flavonoids and 2.5 mg/day of xanthohumol. | Dietary supplement | Hop extract |
| Soy isoflavone extractDescription: 100 mg/day orally, one capsule per day for 12 weeks. Standardized to at least 40% total isoflavones (at least 40 mg/day) and at least 20% genistein (at least 20 mg/day). | Dietary supplement | Soy extract |
Primary outcome
Change in the psychological subscale score of the Menopause Rating Scale (MRS)
Time frame: Baseline (visit 1) and week 12 (visit 3)
The MRS psychological subscale is the sum of items 4 to 7 (depressive mood, irritability, anxiety, and physical and mental exhaustion), each rated from 0 (none) to 4 (very severe). Score range 0 to 16; higher scores indicate greater symptom severity. Change is the week 12 score minus the baseline score.
15 secondary outcomes
Change in total MRS score
Time frame: Baseline, week 6 and week 12
Change in MRS somatic-vegetative subscale score
Time frame: Baseline, week 6 and week 12
Change in MRS urogenital subscale score
Time frame: Baseline, week 6 and week 12
Change in Generalized Anxiety Disorder-7 (GAD-7) score
Time frame: Baseline and week 12 (optional at week 6)
Change in Patient Health Questionnaire-9 (PHQ-9) score
Time frame: Baseline and week 12 (optional at week 6)
Change in the Cervantes Scale global score
Time frame: Baseline and week 12
Change in the Cervantes Scale sexuality domain score
Time frame: Baseline and week 12
Change in body fat percentage
Time frame: Baseline and week 12
Change in estimated visceral fat
Time frame: Baseline and week 12
Change in hot flash intensity (visual analogue scale)
Time frame: Baseline, week 6 and week 12
Change in sleep quality (visual analogue scale)
Time frame: Baseline, week 6 and week 12
Change in mood (visual analogue scale)
Time frame: Baseline, week 6 and week 12
Number of participants with adverse events
Time frame: From baseline to week 12
Change in liver profile
Time frame: Baseline and week 12
Change in lean mass
Time frame: Baseline and week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 15012887Palacios S, Ferrer-Barriendos J, Parrilla JJ, Castelo-Branco C, Manubens M, Alberich X, Marti A; Grupo Cervantes. [Health-related quality of life in the Spanish women through and beyond menopause. Development and validation of the Cervantes Scale]. Med Clin (Barc). 2004 Feb 21;122(6):205-11. doi: 10.1016/s0025-7753(04)74198-6. Spanish.
- Background: PubMed 15345062Heinemann K, Ruebig A, Potthoff P, Schneider HP, Strelow F, Heinemann LA, Do MT. The Menopause Rating Scale (MRS) scale: a methodological review. Health Qual Life Outcomes. 2004 Sep 2;2:45. doi: 10.1186/1477-7525-2-45.
- Background: PubMed 26960416Morimoto-Kobayashi Y, Ohara K, Ashigai H, Kanaya T, Koizumi K, Manabe F, Kaneko Y, Taniguchi Y, Katayama M, Kowatari Y, Kondo S. Matured hop extract reduces body fat in healthy overweight humans: a randomized, double-blind, placebo-controlled parallel group study. Nutr J. 2016 Mar 9;15:25. doi: 10.1186/s12937-016-0144-2.
- Background: PubMed 23512496Keiler AM, Zierau O, Kretzschmar G. Hop extracts and hop substances in treatment of menopausal complaints. Planta Med. 2013 May;79(7):576-9. doi: 10.1055/s-0032-1328330. Epub 2013 Mar 19.
- Individual participant dataSharing planned: No. Individual participant data will not be shared at this stage. Aggregate results will be published in a peer-reviewed journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Silvia Pilar González Rodríguez principal investigator
Menoclínica by Palacios
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full Spectrum hop extract (MENODUO FullSpectrum) and Soy isoflavone extract in people with Menopause and Perimenopause, run by Menoclinica by Palacios at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esmeralda Josa (+34 914 324 499, esmeralda.josa@menoclinica.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the psychological subscale score of the Menopause Rating Scale (MRS) (time frame: Baseline (visit 1) and week 12 (visit 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07904390, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.