Open-labelled Study to Evaluate the Effect of SE5-OH Tablets on Healthy Women With Menopausal Symptoms

A study testing SE5-OH tablets in people with Menopause, run by Nutrition & Sante Iberia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Multicentre, exploratory, prospective, open-labelled study to evaluate the efficacy of SE5-OH tablets on menopausal symptoms in healthy women experiencing menopausal symptoms after 12 weeks of administration. The study will be performed in 10 hospitals (private and public) located in Spain. Read more about this study

Who is it for?: Ages 45 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for: Menopause
What is being tested?: SE5-OH tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 170 participants
Where: 1 siteSpain
Study dates: 17 Mar 2023to 16 Oct 2024
Phase: Interventional
Are there results?: None posted in the registry

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
Healthy volunteers accepted
Adult

Who may be able to join

45-60 years healthy women who have provided signed ICF.
Experiencing menopause symptoms for at least 1 month.
Total MRS score ≥9 at inclusion time (baseline).
MRS with a score equal or above 9 include women with moderate to severe menopausal symptoms according to the validated analysis of this questionnaire.

Who cannot join

Women currently receiving hormone replacement therapy (HRT) or bio identical hormone replacement therapy (BHRT) or have received HRT/BHRT in the last 3 months.
Pregnant, nursing women or women planning to become pregnant*.
Subject with a history or presence of clinically severe disease such as hepatic, renal, endocrine, hematologic, immunologic (including chronic inflammatory conditions) and cancer disease.
History or presence psychosomatic diseases (drug treatment), epilepsy, rheumatism.
Allergies to soy.
History of any food behaviour complication (lacking sufficient intake and/or over intake of food)

Show all 11Show fewer

Intestinal malabsorption that could decrease food supplements intestinal absorption.
Receiving any drug during the last 3 months for menopause symptoms or any food supplement during the last 1 month that could decrease or hide/mask the effect of the experimental product.
Participation to another clinical trial.
Any other medical problem identified by the investigator that could alter the ability of the volunteer to participate to the study including non-treated/non controlled thyroid disease, diabetes (among others).
A negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or HCG equivalent units) must be performed prior to subject enrolment and must be negative 24 hours prior to initiation of study treatment in case of any suspicious.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Clínica Palacios Madrid
Madrid, Madrid

Other trials in Spain

About this study

Official title: Multicentre, Exploratory, Prospective, Open-labelled, Non-controlled Study to Evaluate the Effect of SE5-OH Tablets on Healthy Women With Menopausal Symptoms

The study will be performed in 10 hospitals (private and public) located in Spain. Recruitment period of 6 months will be defined in order to include up to 300 healthy volunteers from different national hospitals and clinics.

Read the detailed description

Multicentre, exploratory, prospective, open-labelled, non-controlled study to evaluate the efficacy of SE5-OH tablets for menopausal symptoms reduction. SE5-OH tablets are a food supplement containing active S-equol. The daily dose of S-equol is 10 mg in the form of 4 tablets of SE5-OH tablets.

The study will be performed in 10 hospitals (private and public) located in Spain to include up to 300 subjects in 6 months of recruitment period.

Investigators will review the medical history from healthy women with moderate to severe menopausal symptoms who are visiting the participating site, investigators will ensure that each candidate meets all the inclusion criteria and none of exclusion criteria. Suitable participants will be informed during the visit about the nature of the investigational study by receiving first information about the investigational product (food supplement) and invited to participate later when all questions have been addressed. A 14 days' period of reflexion is possible for every participant in accordance with Good Clinical Practice.

The procedures involved will be explained in detail and written consent must be obtained with subject and investigators signature before subject participation. The total duration of each participant in the study will be 16 weeks (12 weeks treatment + 4 weeks follow up). The participation in the study is completely voluntary.

The study consists of 4 visits: 3 visits until the end of treatment (EoT) with 1 follow up/end of study visit (FU/EoS) after treatment completion.

SE5-OH tablets will be administrated in tablets (4 per day) by daily oral intake until the day before the end of treatment date (week 12). Non-administrated SE5-OH tablets and VMS diary competition will be verified during the study in the corresponding visits until the EoS (visit 4).

Conditions: Menopause
Being tested: SE5-OH tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SE5-OH tabletsDietary supplement
SE5-OH (Fermented Soy germ, include S-equol), Crystalline cellulose, Oats fiber, Agar, Cyclic oligosaccharide, HPMC, Reduced syrup.

Study groups in NCT06398236
Study group	Role	What they receive
SE5-OH tablets	Experimental	The product under investigation is a food supplement that contains SE5-OH (Fermented Soy germ, include S-equol), Crystalline cellulose, Oats fiber, Agar, Cyclic oligosaccharide, HPMC, Reduced syrup. The food supplement is presented in sealed bottles, each bottle contains 120 tablets with the recommended daily dose of 4 tablets per day administrated orally with a glass of water. The 4 tablets can be administrated together in a unique intake or in 2 separated intakes (2 tablets/intake) along the day. Receives: Dietary Supplement: SE5-OH tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate the efficacy of SE5-OH tablets on menopausal symptoms.
To evaluate the efficacy of SE5-OH tablets on menopausal symptoms with the assessment of the menopausal rating scale (MRS) total scores and subscales scores (somatic, psychological, and urogenital) after 12 weeks of treatment from week 0.
MRS consists of a list of 11 symptoms, that can get 0 (no symptom) or up to 4 scoring points (severe symptom) depending on the severity of the complaints perceived by the women completing the scale.
The total score of the MRS ranges between 0 (asymptomatic) and 44 (highest degree of complaints) and is the sum of the dimension scores. The total score can be categorized into: No little (0-4) / Mild (5-8) / Moderate (9-15) / Severe (≥16).
Higher scores mean worse outcome.
Measured: At week 12 from week 0.

Secondary outcomes (14)

To evaluate the changes in menopausal symptoms.
To evaluate the changes in menopausal symptoms by MRS total scores and subscales scores (somatic, psychological, and urogenital) at week 4 and 16 from week 0.
MRS consists of a list of 11 symptoms, that can get 0 (no symptom) or up to 4 scoring points (severe symptom) depending on the severity of the complaints perceived by the women completing the scale.
The total score of the MRS ranges between 0 (asymptomatic) and 44 (highest degree of complaints) and is the sum of the dimension scores. The total score can be categorized into: No little (0-4) / Mild (5-8) / Moderate (9-15) / Severe (≥16).
Higher scores mean worse outcome.
Measured: At week 4 and 16 from week 0.
To evaluate the changes in vulvovaginal symptoms.
To evaluate the changes in vulvovaginal symptoms by the vulvovaginal symptoms questionnaire (VSQ) total score and subscales score (symptoms, emotions, life-impact, and sexual impact) at week 4, 12 and 16 from week 0.
VSQ consists of a list of 21 items answered as yes (1 point) or no (0 points), and making up a total of four scales:
- Vulvovaginal symptoms: 0 to 7 points (items 1-7)
- Emotions: 0 to 4 points (items 8-11)
- Life-impact: 0 to 4 points (items 12-15)
- Sexual impact: 0 to 5 points (items 16, 18-21) [item 17 asks about sexual activity, if the answer is affirmative then the four scales are evaluated, if it is negative, only the first three] The total score of the VSQ ranges between 0 and 20: the higher the score, the worse the rating
Measured: At week 4, 12 and 16 from week 0.
To evaluate the changes in work performance associated to menopausal symptoms.
To evaluate the changes in work performance associated to menopausal symptoms, the utrecht work engagement scale (UWES) total scores and subscales scores (vigor, dedication, and absorption) at week 12 from week 0.
UWES consists of a list of 17 items, that can get 0 (never) or up to 6 scoring points (always / every day). There are 3 scales:
- Vigor (item 1, 4, 8, 12, 15, 17)
- Dedication (item 2, 5, 7, 10, 13)
- Absorption (item 3, 6, 9, 11, 14, 16) The mean scale score of the three UWES subscales is computed by adding the scores on the particular scale and dividing the sum by the number of items of the subscale involved. A similar procedure if followed for the total score. Hence, the UWES, yields three subscale scores and/or a total score that range between 0 and 6: the higher score, the most work engagement.
Measured: At week 12 from week 0.
To evaluate the changes in pain in joint and hand, shoulder, and low back.
To evaluate the changes in pain in joint and hand, shoulder, and low back by the visual analogue scale (VAS) at week 12 from week 0. Each visual analogue scale scores from 0 to 10. Higher scores mean worse outcome.
Measured: At week 12 from week 0
To evaluate the changes in sleep quality.
To evaluate the changes in sleep quality by the visual analogue scale (VAS) at week 12 from week 0.
Visual analogue scale scores from 0 to 10. Higher scores mean worse outcome.
Measured: At week 12 from week 0.
To evaluate the changes in vasomotor symptoms.
To evaluate the changes in vasomotor symptoms (VMS) such hot flushes and night sweats, a registration of frequency and severity every day during the 16 weeks of subject participation.
The mean number of hot flashes/night sweats by severity (mild, moderate, and severe) reported in the diary will be calculated in each study period.
Measured: At week 4, 12 and 16 from week 0 based on daily registrations.
To evaluate the changes in the vaginal maturation index.
To evaluate the changes in the vaginal maturation index (VMI) by pap smear at week 4, 12 and 16 from week 0.
The VMI is presented as 0/0/0, representing respectively: % parabasal cells, % intermediate cells and % superficial cells.
The VMI is the ratio of different cell types in the vaginal wall (parabasal, intermediate and superficial cells) the presence of one and another type is influenced by oestrogen and progesterone stimulation, which means, that VMI will change throughout a woman's life depending on age and/or reproductive stage. Vaginal pH >5 seems to be associated to dryness and mucosal pallor; hormonal changes could affect either to vaginal pH and vaginal epithelium resulting in signs and symptoms of dryness or dyspareunia among others. Weber et al. concluded in their study that objective assessments such VMI and vaginal pH should be evaluated in conjunction with subjective assessments.
Measured: At week 4, 12 and 16 from week 0.
To evaluate the changes in the vaginal pH.
To evaluate the changes in the vaginal pH (VpH) by a pH determination at week 4, 12 and 16 from week 0.
Measured: At week 4, 12 and 16 from week 0.
To evaluate the changes in body mass index (BMI).
To evaluate the changes in body mass index (BMI) at week 12 from week 0. Weight and height will be combined to report BMI in kg/m^2
Measured: At week 12 from week 0.
To evaluate the changes in blood pressure (BP).
To evaluate the changes in blood pressure (BP) at week 12 from week 0. Systolic and Diastolic Blood Pressure will be reported in mmHg.
Measured: At week 16
To evaluate the variability of equol producers and equol non-producers among the subjects.
Equol producers vs non-equol producers will be described at week 16 by means of results from urine analysis:
- S-equol concentration
- Daidzein concentration
- S-equol/daidzein Log10 The patients will be classified into equol producer / non-producer / indeterminate, considering that daidzein ratio of -1.75 provided a demarcation to define equol producer status.
Measured: At week 16
To evaluate the adverse events.
Adverse events (in terms of severity, intensity, causal relationship and outcome) will be assessed during the 16 weeks of study participation.
Measured: Up to 16 weeks.
To evaluate tolerability.
The perception of tolerability by subject and investigator will be described at week 16. It will be measured with the folowing scale: excelent/good/moderate/poor/not evaluated by each one of them.
Measured: At week 16
To evaluate the compliance.
Compliance (in terms of poor, moderate good and very good) during the 12 weeks of treatment administration.
Measured: At week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Mar 202316 Oct 2024

First posted3 May 2024
Study start17 Mar 2023
Primary completion18 Jul 2024
Study completion16 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (41)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: Other
Allocation: Not applicable
Intervention model: Single group
Model description: Multicentre, exploratory, prospective, open-labelled study to evaluate the efficacy of SE5-OH tablets on menopausal symptoms in healthy women experiencing menopausal symptoms after 12 weeks of administration.
Masking: None (open label)
Enrolment: 170 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06398236
Sponsor's protocol ID: EQUELLE_22_01
Status last verified: Jul 2025
First submitted: 9 Apr 2024
Last updated: 8 Jul 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Goodman NF, Cobin RH, Ginzburg SB, Katz IA, Woode DE; American Association of Clinical Endocrinologists. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the diagnosis and treatment of menopause. Endocr Pract. 2011 Nov-Dec;17 Suppl 6:1-25. doi: 10.4158/ep.17.s6.1. No abstract available.
PubMed 22193047
Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and The North American Menopause Society. Climacteric. 2014 Oct;17(5):557-63. doi: 10.3109/13697137.2014.946279. Epub 2014 Aug 25.
PubMed 25153131
Lu CB, Liu PF, Zhou YS, Meng FC, Qiao TY, Yang XJ, Li XY, Xue Q, Xu H, Liu Y, Han Y, Zhang Y. Musculoskeletal Pain during the Menopausal Transition: A Systematic Review and Meta-Analysis. Neural Plast. 2020 Nov 25;2020:8842110. doi: 10.1155/2020/8842110. eCollection 2020.
PubMed 33299396
Delamater L, Santoro N. Management of the Perimenopause. Clin Obstet Gynecol. 2018 Sep;61(3):419-432. doi: 10.1097/GRF.0000000000000389.
PubMed 29952797
Avis NE, Stellato R, Crawford S, Bromberger J, Ganz P, Cain V, Kagawa-Singer M. Is there a menopausal syndrome? Menopausal status and symptoms across racial/ethnic groups. Soc Sci Med. 2001 Feb;52(3):345-56. doi: 10.1016/s0277-9536(00)00147-7.
PubMed 11330770
Couzi RJ, Helzlsouer KJ, Fetting JH. Prevalence of menopausal symptoms among women with a history of breast cancer and attitudes toward estrogen replacement therapy. J Clin Oncol. 1995 Nov;13(11):2737-44. doi: 10.1200/JCO.1995.13.11.2737.
PubMed 7595732
Palacios S, Stevenson JC, Schaudig K, Lukasiewicz M, Graziottin A. Hormone therapy for first-line management of menopausal symptoms: Practical recommendations. Womens Health (Lond). 2019 Jan-Dec;15:1745506519864009. doi: 10.1177/1745506519864009.
PubMed 31378196
Marjoribanks J, Farquhar C, Roberts H, Lethaby A, Lee J. Long-term hormone therapy for perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2017 Jan 17;1(1):CD004143. doi: 10.1002/14651858.CD004143.pub5.
PubMed 28093732
Nappi RE, Kroll R, Siddiqui E, Stoykova B, Rea C, Gemmen E, Schultz NM. Global cross-sectional survey of women with vasomotor symptoms associated with menopause: prevalence and quality of life burden. Menopause. 2021 May 24;28(8):875-882. doi: 10.1097/GME.0000000000001793.
PubMed 34033602
Krizova L, Dadakova K, Kasparovska J, Kasparovsky T. Isoflavones. Molecules. 2019 Mar 19;24(6):1076. doi: 10.3390/molecules24061076.
PubMed 30893792
Setchell KD, Clerici C. Equol: history, chemistry, and formation. J Nutr. 2010 Jul;140(7):1355S-62S. doi: 10.3945/jn.109.119776. Epub 2010 Jun 2.
PubMed 20519412
Mayo B, Vazquez L, Florez AB. Equol: A Bacterial Metabolite from The Daidzein Isoflavone and Its Presumed Beneficial Health Effects. Nutrients. 2019 Sep 16;11(9):2231. doi: 10.3390/nu11092231.
PubMed 31527435
Weber MA, Limpens J, Roovers JP. Assessment of vaginal atrophy: a review. Int Urogynecol J. 2015 Jan;26(1):15-28. doi: 10.1007/s00192-014-2464-0. Epub 2014 Jul 22.
PubMed 25047897
Messina M, Nagata C, Wu AH. Estimated Asian adult soy protein and isoflavone intakes. Nutr Cancer. 2006;55(1):1-12. doi: 10.1207/s15327914nc5501_1.
PubMed 16965235
Setchell KD, Clerici C, Lephart ED, Cole SJ, Heenan C, Castellani D, Wolfe BE, Nechemias-Zimmer L, Brown NM, Lund TD, Handa RJ, Heubi JE. S-equol, a potent ligand for estrogen receptor beta, is the exclusive enantiomeric form of the soy isoflavone metabolite produced by human intestinal bacterial flora. Am J Clin Nutr. 2005 May;81(5):1072-9. doi: 10.1093/ajcn/81.5.1072.
PubMed 15883431

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicentre, Exploratory, Prospective, Open-labelled, Non-controlled Study to Evaluate the Effect of SE5-OH Tablets on Healthy Women With Menopausal Symptoms
ClinicalTrials.gov ID: NCT06398236
Acronym / sponsor ID: EQUELLE_22_01
Conditions: Menopause
Study type: Interventional
Recruitment status: Completed
Enrolment: 170 participants (actual)
Lead sponsor: Nutrition & Sante IberiaIndustry (pharma, biotech, devices)
Collaborators: Adknoma Health Research
Study start: 17 Mar 2023 (actual)
Primary completion: 18 Jul 2024 (actual)
Study completion: 16 Oct 2024 (actual)
First posted: 3 May 2024 (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.

Detailed description

The study will be performed in 10 hospitals (private and public) located in Spain to include up to 300 subjects in 6 months of recruitment period.

The study consists of 4 visits: 3 visits until the end of treatment (EoT) with 1 follow up/end of study visit (FU/EoS) after treatment completion.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Multicentre, exploratory, prospective, open-labelled study to evaluate the efficacy of SE5-OH tablets on menopausal symptoms in healthy women experiencing menopausal symptoms after 12 weeks of administration.

Arm	Type	Receives
SE5-OH tablets	Experimental	Dietary Supplement: SE5-OH tabletsThe product under investigation is a food supplement that contains SE5-OH (Fermented Soy germ, include S-equol), Crystalline cellulose, Oats fiber, Agar, Cyclic oligosaccharide, HPMC, Reduced syrup. The food supplement is presented in sealed bottles, each bottle contains 120 tablets with the recommended daily dose of 4 tablets per day administrated orally with a glass of water. The 4 tablets can be administrated together in a unique intake or in 2 separated intakes (2 tablets/intake) along the day.

Who may qualify

Ages: 45 to 60 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

45-60 years healthy women who have provided signed ICF.
Experiencing menopause symptoms for at least 1 month.
Total MRS score ≥9 at inclusion time (baseline).
MRS with a score equal or above 9 include women with moderate to severe menopausal symptoms according to the validated analysis of this questionnaire.

Key exclusion criteria (11 listed)

Women currently receiving hormone replacement therapy (HRT) or bio identical hormone replacement therapy (BHRT) or have received HRT/BHRT in the last 3 months.
Pregnant, nursing women or women planning to become pregnant*.
Subject with a history or presence of clinically severe disease such as hepatic, renal, endocrine, hematologic, immunologic (including chronic inflammatory conditions) and cancer disease.
History or presence psychosomatic diseases (drug treatment), epilepsy, rheumatism.
Allergies to soy.

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
SE5-OH tabletsSE5-OH (Fermented Soy germ, include S-equol), Crystalline cellulose, Oats fiber, Agar, Cyclic oligosaccharide, HPMC, Reduced syrup.	Dietary supplement	SE5-OH tablets

Primary outcome

To evaluate the efficacy of SE5-OH tablets on menopausal symptoms.
Time frame: At week 12 from week 0.
To evaluate the efficacy of SE5-OH tablets on menopausal symptoms with the assessment of the menopausal rating scale (MRS) total scores and subscales scores (somatic, psychological, and urogenital) after 12 weeks of treatment from week 0. MRS consists of a list of 11 symptoms, that can get 0 (no symptom) or up to 4 scoring points (severe symptom) depending on the severity of the complaints perceived by the women completing the scale. The total score of the MRS ranges between 0 (asymptomatic) and 44 (highest degree of complaints) and is the sum of the dimension scores. The total score can be categorized into: No little (0-4) / Mild (5-8) / Moderate (9-15) / Severe (≥16). Higher scores mean worse outcome.

14 secondary outcomes

To evaluate the changes in menopausal symptoms.
Time frame: At week 4 and 16 from week 0.
To evaluate the changes in vulvovaginal symptoms.
Time frame: At week 4, 12 and 16 from week 0.
To evaluate the changes in work performance associated to menopausal symptoms.
Time frame: At week 12 from week 0.
To evaluate the changes in pain in joint and hand, shoulder, and low back.
Time frame: At week 12 from week 0
To evaluate the changes in sleep quality.
Time frame: At week 12 from week 0.
To evaluate the changes in vasomotor symptoms.
Time frame: At week 4, 12 and 16 from week 0 based on daily registrations.
To evaluate the changes in the vaginal maturation index.
Time frame: At week 4, 12 and 16 from week 0.
To evaluate the changes in the vaginal pH.
Time frame: At week 4, 12 and 16 from week 0.
To evaluate the changes in body mass index (BMI).
Time frame: At week 12 from week 0.
To evaluate the changes in blood pressure (BP).
Time frame: At week 16
To evaluate the variability of equol producers and equol non-producers among the subjects.
Time frame: At week 16
To evaluate the adverse events.
Time frame: Up to 16 weeks.
To evaluate tolerability.
Time frame: At week 16
To evaluate the compliance.
Time frame: At week 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
Background: PubMed 22193047Goodman NF, Cobin RH, Ginzburg SB, Katz IA, Woode DE; American Association of Clinical Endocrinologists. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the diagnosis and treatment of menopause. Endocr Pract. 2011 Nov-Dec;17 Suppl 6:1-25. doi: 10.4158/ep.17.s6.1. No abstract available.
Background: PubMed 25153131Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and The North American Menopause Society. Climacteric. 2014 Oct;17(5):557-63. doi: 10.3109/13697137.2014.946279. Epub 2014 Aug 25.
Background: PubMed 33299396Lu CB, Liu PF, Zhou YS, Meng FC, Qiao TY, Yang XJ, Li XY, Xue Q, Xu H, Liu Y, Han Y, Zhang Y. Musculoskeletal Pain during the Menopausal Transition: A Systematic Review and Meta-Analysis. Neural Plast. 2020 Nov 25;2020:8842110. doi: 10.1155/2020/8842110. eCollection 2020.
Background: PubMed 29952797Delamater L, Santoro N. Management of the Perimenopause. Clin Obstet Gynecol. 2018 Sep;61(3):419-432. doi: 10.1097/GRF.0000000000000389.
Background: PubMed 11330770Avis NE, Stellato R, Crawford S, Bromberger J, Ganz P, Cain V, Kagawa-Singer M. Is there a menopausal syndrome? Menopausal status and symptoms across racial/ethnic groups. Soc Sci Med. 2001 Feb;52(3):345-56. doi: 10.1016/s0277-9536(00)00147-7.
Background: PubMed 7595732Couzi RJ, Helzlsouer KJ, Fetting JH. Prevalence of menopausal symptoms among women with a history of breast cancer and attitudes toward estrogen replacement therapy. J Clin Oncol. 1995 Nov;13(11):2737-44. doi: 10.1200/JCO.1995.13.11.2737.
Background: PubMed 31378196Palacios S, Stevenson JC, Schaudig K, Lukasiewicz M, Graziottin A. Hormone therapy for first-line management of menopausal symptoms: Practical recommendations. Womens Health (Lond). 2019 Jan-Dec;15:1745506519864009. doi: 10.1177/1745506519864009.
Background: PubMed 28093732Marjoribanks J, Farquhar C, Roberts H, Lethaby A, Lee J. Long-term hormone therapy for perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2017 Jan 17;1(1):CD004143. doi: 10.1002/14651858.CD004143.pub5.
Background: PubMed 34033602Nappi RE, Kroll R, Siddiqui E, Stoykova B, Rea C, Gemmen E, Schultz NM. Global cross-sectional survey of women with vasomotor symptoms associated with menopause: prevalence and quality of life burden. Menopause. 2021 May 24;28(8):875-882. doi: 10.1097/GME.0000000000001793.
Background: PubMed 30893792Krizova L, Dadakova K, Kasparovska J, Kasparovsky T. Isoflavones. Molecules. 2019 Mar 19;24(6):1076. doi: 10.3390/molecules24061076.
Background: PubMed 20519412Setchell KD, Clerici C. Equol: history, chemistry, and formation. J Nutr. 2010 Jul;140(7):1355S-62S. doi: 10.3945/jn.109.119776. Epub 2010 Jun 2.
Background: PubMed 31527435Mayo B, Vazquez L, Florez AB. Equol: A Bacterial Metabolite from The Daidzein Isoflavone and Its Presumed Beneficial Health Effects. Nutrients. 2019 Sep 16;11(9):2231. doi: 10.3390/nu11092231.

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SE5-OH tablets in people with Menopause, run by Nutrition & Sante Iberia 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 8 Jul 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the efficacy of SE5-OH tablets on menopausal symptoms. (time frame: At week 12 from week 0.). 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 NCT06398236, which also lists 41 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 8 Jul 2025.