Menopausal SyndromeNCT07739615
Effect of Soya Bean on the Female Reproductive Hormones and Menopausal Symptoms
A study testing Soy Bean in people with Menopausal Syndrome, run by Alex Ekwueme Federal University Teaching Hospital.
Trial summary
Menopause is one of the most emotionally, physically and Psychological miserable times in a woman's life.It occurs following cessation of menses resulting in the decline of endogenous estrogen. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal Syndrome
- What is being tested?
- Soy Bean
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Aug 2026
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women who gave consent
- Absence of Menses for more than 1year that is not due to medical treatment
- More than 40years of age
Who cannot join
- Women on hormone replacement therapy
- Women on any hormonal medication
- Allergy to soya products.
- 40year old or lesser
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Menopause is one of the most emotionally, physically and Psychological miserable times in a woman's life.It occurs following cessation of menses resulting in the decline of endogenous estrogen. Phytoestrogens are natural plant derived compounds found in a wide variety of foods and soy bean is considered to be the richest source of plant estrogens. Current advances in management of menopause have relied on the use of hormone replacement therapy; however they are associated with adverse side effects if used over a long period of time. Currently, there is varying opinion regarding the physiological impact of soy bean consumption and results of studies are sparse and inconclusive. Hence, the need to determine the effect of soya bean consumption on the female reproductive hormones and relief of menopausal symptoms
Read the detailed description
Menopause is one of the most emotionally, physically and Psychological miserable times in a woman's life.It occurs following cessation of menses resulting in the decline of endogenous estrogen. Phytoestrogens are natural plant derived compounds found in a wide variety of foods and soy bean is considered to be the richest source of plant estrogens. Current advances in management of menopause have relied on the use of hormone replacement therapy; however they are associated with adverse side effects if used over a long period of time. Currently, there is varying opinion regarding the physiological impact of soy bean consumption and results of studies are sparse and inconclusive. Hence, the need to determine the effect of soya bean consumption on the female reproductive hormones and relief of menopausal symptoms.
Sixty nine postmenopausal women will be randomized into three groups of 23 each. Group 1received 50g daily of the soya bean powder as tea for 28days, Group 2 received 100g daily of the soya bean powder as tea for 28days and Group 3 was on their normal diet and acts as control for 28days. Questionnaire and blood samples will be collected before and after the 28days for analysis. Blood will be assayed for the female reproductive hormone(Estrogen, Progesterone, Antimullerin hormone, FSH and LH), while standardized questionnaire will be used to get information on about objective of the study.
The generated data will be analyzed with International Business Machine Statistical Package for Social Science (IBM-SPSS) software version 22(Chicago II, USA) 2015. Students' t-test (t-test) will be used for comparison between groups for continuous variables while chi-square (χ2) test will be used for categorical variables. Values were expressed as mean ± SD. Statistical significance will be considered at P<0.05.
- Conditions
- Menopausal Syndrome
- Being tested
- Soy Bean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy BeanDietary supplement
Soya bean is a phytoestrogen
| Study group | Role | What they receive |
|---|---|---|
| 50g Soya bean Group | Experimental | Received 50g daily of the soya bean powder as tea for 28days and their usual daily diet Receives: Dietary Supplement: Soy Bean |
| 100g Soya bean group | Experimental | Received 100g daily of the soya bean powder as tea for 28days and their usual daily diet Receives: Dietary Supplement: Soy Bean |
| Normal Diet group | No intervention | Was on their usual daily diet and acted as control for 28days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Reproductive hormones
Analysis of the Serum estrogen, progesterone, follicle stimulating hormone, lutenizing hormone and antimullerian hormone
Measured: 28days
Secondary outcomes (1)
Changes in menopausal symtoms
Using questionaire and standardised tools to collect information about menopausal symtoms
Measured: 28days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal SyndromeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 50g Soya bean Group: Received 50g daily of the soya bean powder as tea for 28days and their usual daily diet 100g Soya bean Group: Received 100g daily of the soya bean powder as tea for 28days and their usual daily diet Normal diet Group: Was on their usual daily diet and acted as control for 28days.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alex Ekwueme Federal University Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darlington-Peter Chibuzor Ugoji, Alex Ekwueme Federal University Teaching Hospital
- Investigators
- DARLINTON-PETER CHIBUZOR UGOJI, Principal investigator, DAVID UMAHI FEDERAL UNIVERSITY TEACHING HOSPITAL UBURU, EBONYI STATE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739615
- Sponsor's protocol ID
- EBSHREC 04/040
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Staticstics to be shared after the work
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Soya Bean on the Female Reproductive Hormones and Menopausal Symptoms
- ClinicalTrials.gov ID
- NCT07739615
- Acronym / sponsor ID
- EBSHREC 04/040
- Conditions
- Menopausal Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Alex Ekwueme Federal University Teaching HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 31 Jul 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.
Menopause is one of the most emotionally, physically and Psychological miserable times in a woman's life.It occurs following cessation of menses resulting in the decline of endogenous estrogen. Phytoestrogens are natural plant derived compounds found in a wide variety of foods and soy bean is considered to be the richest source of plant estrogens. Current advances in management of menopause have relied on the use of hormone replacement therapy; however they are associated with adverse side effects if used over a long period of time. Currently, there is varying opinion regarding the physiological impact of soy bean consumption and results of studies are sparse and inconclusive. Hence, the need to determine the effect of soya bean consumption on the female reproductive hormones and relief of menopausal symptoms
Detailed description
Menopause is one of the most emotionally, physically and Psychological miserable times in a woman's life.It occurs following cessation of menses resulting in the decline of endogenous estrogen. Phytoestrogens are natural plant derived compounds found in a wide variety of foods and soy bean is considered to be the richest source of plant estrogens. Current advances in management of menopause have relied on the use of hormone replacement therapy; however they are associated with adverse side effects if used over a long period of time. Currently, there is varying opinion regarding the physiological impact of soy bean consumption and results of studies are sparse and inconclusive. Hence, the need to determine the effect of soya bean consumption on the female reproductive hormones and relief of menopausal symptoms.
Sixty nine postmenopausal women will be randomized into three groups of 23 each. Group 1received 50g daily of the soya bean powder as tea for 28days, Group 2 received 100g daily of the soya bean powder as tea for 28days and Group 3 was on their normal diet and acts as control for 28days. Questionnaire and blood samples will be collected before and after the 28days for analysis. Blood will be assayed for the female reproductive hormone(Estrogen, Progesterone, Antimullerin hormone, FSH and LH), while standardized questionnaire will be used to get information on about objective of the study.
The generated data will be analyzed with International Business Machine Statistical Package for Social Science (IBM-SPSS) software version 22(Chicago II, USA) 2015. Students' t-test (t-test) will be used for comparison between groups for continuous variables while chi-square (χ2) test will be used for categorical variables. Values were expressed as mean ± SD. Statistical significance will be considered at P<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 50g Soya bean Group: Received 50g daily of the soya bean powder as tea for 28days and their usual daily diet 100g Soya bean Group: Received 100g daily of the soya bean powder as tea for 28days and their usual daily diet Normal diet Group: Was on their usual daily diet and acted as control for 28days.
| Arm | Type | Receives |
|---|---|---|
| 50g Soya bean Group | Experimental | Dietary Supplement: Soy BeanReceived 50g daily of the soya bean powder as tea for 28days and their usual daily diet |
| 100g Soya bean group | Experimental | Dietary Supplement: Soy BeanReceived 100g daily of the soya bean powder as tea for 28days and their usual daily diet |
| Normal Diet group | No intervention | –Was on their usual daily diet and acted as control for 28days. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Women who gave consent
- Absence of Menses for more than 1year that is not due to medical treatment
- More than 40years of age
Key exclusion criteria (4 listed)
- Women on hormone replacement therapy
- Women on any hormonal medication
- Allergy to soya products.
- 40year old or lesser
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 |
|---|---|---|
| Soy BeanSoya bean is a phytoestrogen | Dietary supplement | 100g Soya bean group, 50g Soya bean Group |
Primary outcome
Changes in the Reproductive hormones
Time frame: 28days
Analysis of the Serum estrogen, progesterone, follicle stimulating hormone, lutenizing hormone and antimullerian hormone
1 secondary outcome
Changes in menopausal symtoms
Time frame: 28days
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 31 Jul 2026.
- Individual participant dataSharing planned: Yes. Staticstics to be shared after the work
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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.
DARLINTON-PETER CHIBUZOR UGOJI principal investigator
DAVID UMAHI FEDERAL UNIVERSITY TEACHING HOSPITAL UBURU, EBONYI STATE
Questions about this trial
What is this clinical trial studying?
A study testing Soy Bean in people with Menopausal Syndrome, run by Alex Ekwueme Federal University Teaching Hospital.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 DARLINTON-PETER CHIBUZOR UGOJI, FELLOWSHIP (08068748644, darlingtonpeter2012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Reproductive hormones (time frame: 28days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.