HypogonadismPhase 4NCT03057899
Efficacy of Fenugreek Seed and Lespedeza Cuneata in TDS
A Phase 4 study testing TFG capsules (200 mg /capsule) in people with Hypogonadism, run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
Objective: The aim of this study was to investigate the efficacy and safety of a mixed extract of fenugreek seed and Lespedeza cuneata (TFG) for the treatment of testosterone deficiency syndrome (TDS). Design: Patients were instructed to take a placebo capsule or 200 mg TFG capsule twice per day for 8 weeks. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Hypogonadism
- What is being tested?
- TFG capsules (200 mg /capsule)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2015to Dec 2015
- Phase
- Phase 4
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- total scores on the Aging Males' Symptoms scale (AMS) questionnaire ≥ 27; total serum cholesterol <220 mg/dl; and triglyceride 150-399 mg/dl
Who cannot join
- diagnosis of another sexual disorder, serum creatinine > 2.5 mg/dL, an uncontrolled psychiatric disorder, history of major hematological, renal, or hepatic abnormalities, body mass index ≥ 45 kg/m2, HBsAg (hepatitis B surface antigen) positive, prostate specific antigen (PSA) ≥ 4.0 ng/ml, cardiac failure, or a history of alcoholism or substance abuse. Patients who had taken PDE5 inhibitors, TRT, anti-androgen, statins, fibrates, niacin, steroid, fish oil, colestin, fiber-based laxatives, phytosterol margarines, anti-diabetics, anti-platelet, thyroxine, diuretics, or beta-blockers were also excluded.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Urology, Pusan National University Hospital
Busan, 602-739
About this study
Official title: Efficacy and Safety of a Mixed Extract of Fenugreek Seed and Lespedeza Cuneata in the Treatment of Testosterone Deficiency Syndrome: A Randomized, Double-blind, Placebo-Controlled Clinical Trial
Objective: The aim of this study was to investigate the efficacy and safety of a mixed extract of fenugreek seed and Lespedeza cuneata (TFG) for the treatment of testosterone deficiency syndrome (TDS).
Design: Patients were instructed to take a placebo capsule or 200 mg TFG capsule twice per day for 8 weeks.
Outcome measures: The primary efficacy variable was the change from baseline in the Aging Males' Symptoms scale (AMS), as well as levels of serum total testosterone and free testosterone. Secondary efficacy measurements included changes from baseline in the number of 'yes' answers on the Androgen Deficiency in the Aging Male questionnaire (ADAM), levels of serum total cholesterol, HDL-C, LDL-C, triglyceride, perceived stress scale (PSS-10), all domain scores of the International Index of Erectile Function (IIEF), as well as changes in body composition.
Read the detailed description
Testosterone deficiency syndrome (TDS) is "a clinical and biochemical syndrome associated with advancing age and characterized by symptoms of a deficiency in serum testosterone levels". TDS can cause a significant decrease in quality of life and has many adverse effects on multiple organs in terms of men's health. In addition to the detrimental effect of sexual functions, men with TDS tend to have increased waist circumference, hyperglycemia, hypertriglyceridemia, hyperlipidemia, and a history of diabetes. TDS can be treated with testosterone replacement therapy (TRT). TRT should be initiated on an individualized basis in TDS patients who have clinical signs and symptoms of androgen deficiency if the benefits of treatment appear to outweigh the potential risks and only after thorough discussion with the patient. Different preparations of testosterone are currently available. The majority of clinical data shows that TRT is very safe and effective. There is currently no evidence that testosterone treatment increases the risk of prostate disease using modern guidelines. However, the fear of prostate cancer and the risk of erythrocytosis may represent the main limitations of TRT in aging men. Additionally, TRT cannot improve the function of Leydig cells (which produce testosterone), but only compensate for the lack of testosterone.
Limited research has focused on the use of herbal medicine to improve male health, particularly to increase testosterone levels and support healthy sexual function. Despite the increasing availability of effective conventional medical treatments, plant-derived and herbo-mineral remedies continue to be a popular alternative for men seeking to improve sexual function.
Trigonella foenum-graecum Linn, also known as fenugreek, is an aromatic annual plant that reaches heights of 30-60 cm. It is found wild in Kashmir, Punjab, and the upper Gangetic plains, and is widely cultivated in many parts of India. It is used internally as an abortifacient, antispasmodic, appetite stimulant, blood cleanser, laxative, tonic, and expectorant. It is also indicated externally for abscesses, boils, galactagogue, and for its demulcent and emollient properties. The seeds contain diosgenin along with three minor steroidal saponins (similagenin, savsalpogenin, and yuccagenin), choline, trimethylamine (a sex hormone in frogs), vitamins (A, B2, B6, B12, D), lysine, l-tryptophan rich proteins, mucilaginous fiber, coumarin, fenugreekine, nicotinic acid, sapogenins, phytic acid, scopletin and trigonelline, calcium, iron, β-carotene, and other vitamins and essential oils.
Previous studies have suggested that Trigonella foenum-graecum seed extract has positive effects on sexual health and quality of life, and that it demonstrates anabolic and androgenic activity in young patients. It is believed that these positive effects are due to increased testosterone, including free testosterone, and that Trigonella foenum-graecum seed extract may be an effective treatment for the symptoms of possible testosterone deficiency in aging men. The basis for this androgenic activity may be due to the fact that Trigonella foenum-graecum seeds contain soluble steroidal saponins, specifically furostanol glycosides, which are responsible for complexing cholesterol in the cell membrane. Other studies have found that Trigonella foenum-graecum increases testosterone and free testosterone, suggesting that it may be an incomplete 5-alpha reductase and aromatase inhibitor. The investigators investigated the efficacy and safety of a mixed extract of Trigonella foenum-graecum seed and lespedeza cuneata (TFG) for the treatment of TDS.
- Conditions
- Hypogonadism
- Being tested
- TFG capsules (200 mg /capsule), Placebo oral capsule
- Keywords
- Herbal medicine, phytotherapy, testosterone
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TFG capsules (200 mg /capsule)Drug
Also called mixed extract of fenugreek seed and Lespedeza cuneata (TFG)
TFG capsules were prepared using extracts from Trigonella foenum-graecum seed and Lespedeza cuneata. During the study period, two capsules were taken daily for 8 weeks.
Placebo oral capsuleDrug
Also called Placebo capsule
During the study period, two capsules were taken daily for 8 weeks. Placebo and TFG capsules were identical in shape, color, and taste.
| Study group | Role | What they receive |
|---|---|---|
| fenugreek seed and Lespedeza cuneata (TFG) | Experimental | Patients who received investigational products (200 mg TFG) twice per day for 8 weeks at least 30 minutes after food intake Receives: Drug: TFG capsules (200 mg /capsule) |
| Placebo | Placebo comparator | Patients who received placebo twice per day for 8 weeks at least 30 minutes after food intake Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aging Males' Symptoms (AMS) scale
Measured: 4 week
level of serum total testosterone
Measured: 4 week
level of serum free testosterone
Measured: 4 week
Aging Males' Symptoms (AMS) scale
Measured: 8 week
level of serum total testosterone
Measured: 8 week
level of serum free testosterone
Measured: 8week
Secondary outcomes (7)
percentage of positivity on the Androgen Deficiency in Aging Males (ADAM) questionnaire
Measured: 8 week
level of serum total cholesterol
Measured: 8 week
level of serum HDL-C
Measured: 8 week
level of serum LDL-C
Measured: 8 week
level of serum triglyceride
Measured: 8 week
perceived stress scale (PSS)-10
Measured: 8 week
Scores of the International Index of Erectile Function (IIEF)
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study startJun 2015
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Jun Park, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057899
- Sponsor's protocol ID
- Fenugreek for TDS
- Status last verified
- Feb 2017
- First submitted
- 11 Feb 2017
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Mixed Extract of Fenugreek Seed and Lespedeza Cuneata in the Treatment of Testosterone Deficiency Syndrome: A Randomized, Double-blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03057899
- Acronym / sponsor ID
- Fenugreek for TDS
- Conditions
- Hypogonadism
- Keywords
- Herbal medicine, phytotherapy, testosterone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Feb 2017 (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.
Objective: The aim of this study was to investigate the efficacy and safety of a mixed extract of fenugreek seed and Lespedeza cuneata (TFG) for the treatment of testosterone deficiency syndrome (TDS).
Design: Patients were instructed to take a placebo capsule or 200 mg TFG capsule twice per day for 8 weeks.
Outcome measures: The primary efficacy variable was the change from baseline in the Aging Males' Symptoms scale (AMS), as well as levels of serum total testosterone and free testosterone. Secondary efficacy measurements included changes from baseline in the number of 'yes' answers on the Androgen Deficiency in the Aging Male questionnaire (ADAM), levels of serum total cholesterol, HDL-C, LDL-C, triglyceride, perceived stress scale (PSS-10), all domain scores of the International Index of Erectile Function (IIEF), as well as changes in body composition.
Detailed description
Testosterone deficiency syndrome (TDS) is "a clinical and biochemical syndrome associated with advancing age and characterized by symptoms of a deficiency in serum testosterone levels". TDS can cause a significant decrease in quality of life and has many adverse effects on multiple organs in terms of men's health. In addition to the detrimental effect of sexual functions, men with TDS tend to have increased waist circumference, hyperglycemia, hypertriglyceridemia, hyperlipidemia, and a history of diabetes. TDS can be treated with testosterone replacement therapy (TRT). TRT should be initiated on an individualized basis in TDS patients who have clinical signs and symptoms of androgen deficiency if the benefits of treatment appear to outweigh the potential risks and only after thorough discussion with the patient. Different preparations of testosterone are currently available. The majority of clinical data shows that TRT is very safe and effective. There is currently no evidence that testosterone treatment increases the risk of prostate disease using modern guidelines. However, the fear of prostate cancer and the risk of erythrocytosis may represent the main limitations of TRT in aging men. Additionally, TRT cannot improve the function of Leydig cells (which produce testosterone), but only compensate for the lack of testosterone.
Limited research has focused on the use of herbal medicine to improve male health, particularly to increase testosterone levels and support healthy sexual function. Despite the increasing availability of effective conventional medical treatments, plant-derived and herbo-mineral remedies continue to be a popular alternative for men seeking to improve sexual function.
Trigonella foenum-graecum Linn, also known as fenugreek, is an aromatic annual plant that reaches heights of 30-60 cm. It is found wild in Kashmir, Punjab, and the upper Gangetic plains, and is widely cultivated in many parts of India. It is used internally as an abortifacient, antispasmodic, appetite stimulant, blood cleanser, laxative, tonic, and expectorant. It is also indicated externally for abscesses, boils, galactagogue, and for its demulcent and emollient properties. The seeds contain diosgenin along with three minor steroidal saponins (similagenin, savsalpogenin, and yuccagenin), choline, trimethylamine (a sex hormone in frogs), vitamins (A, B2, B6, B12, D), lysine, l-tryptophan rich proteins, mucilaginous fiber, coumarin, fenugreekine, nicotinic acid, sapogenins, phytic acid, scopletin and trigonelline, calcium, iron, β-carotene, and other vitamins and essential oils.
Previous studies have suggested that Trigonella foenum-graecum seed extract has positive effects on sexual health and quality of life, and that it demonstrates anabolic and androgenic activity in young patients. It is believed that these positive effects are due to increased testosterone, including free testosterone, and that Trigonella foenum-graecum seed extract may be an effective treatment for the symptoms of possible testosterone deficiency in aging men. The basis for this androgenic activity may be due to the fact that Trigonella foenum-graecum seeds contain soluble steroidal saponins, specifically furostanol glycosides, which are responsible for complexing cholesterol in the cell membrane. Other studies have found that Trigonella foenum-graecum increases testosterone and free testosterone, suggesting that it may be an incomplete 5-alpha reductase and aromatase inhibitor. The investigators investigated the efficacy and safety of a mixed extract of Trigonella foenum-graecum seed and lespedeza cuneata (TFG) for the treatment of TDS.
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 |
|---|---|---|
| fenugreek seed and Lespedeza cuneata (TFG) | Experimental | Drug: TFG capsules (200 mg /capsule)Patients who received investigational products (200 mg TFG) twice per day for 8 weeks at least 30 minutes after food intake |
| Placebo | Placebo comparator | Drug: Placebo oral capsulePatients who received placebo twice per day for 8 weeks at least 30 minutes after food intake |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- total scores on the Aging Males' Symptoms scale (AMS) questionnaire ≥ 27; total serum cholesterol <220 mg/dl; and triglyceride 150-399 mg/dl
Key exclusion criteria (1 listed)
- diagnosis of another sexual disorder, serum creatinine > 2.5 mg/dL, an uncontrolled psychiatric disorder, history of major hematological, renal, or hepatic abnormalities, body mass index ≥ 45 kg/m2, HBsAg (hepatitis B surface antigen) positive, prostate specific antigen (PSA) ≥ 4.0 ng/ml, cardiac failure, or a history of alcoholism or substance abuse. Patients who had taken PDE5 inhibitors, TRT, anti-androgen, statins, fibrates, niacin, steroid, fish oil, colestin, fiber-based laxatives, phytosterol margarines, anti-diabetics, anti-platelet, thyroxine, diuretics, or beta-blockers were also excluded.
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 |
|---|---|---|
| TFG capsules (200 mg /capsule)Also: mixed extract of fenugreek seed and Lespedeza cuneata (TFG)TFG capsules were prepared using extracts from Trigonella foenum-graecum seed and Lespedeza cuneata. During the study period, two capsules were taken daily for 8 weeks. | Drug | fenugreek seed and Lespedeza cuneata (TFG) |
| Placebo oral capsuleAlso: Placebo capsuleDuring the study period, two capsules were taken daily for 8 weeks. Placebo and TFG capsules were identical in shape, color, and taste. | Drug | Placebo |
Primary outcome
Aging Males' Symptoms (AMS) scale
Time frame: 4 week
level of serum total testosterone
Time frame: 4 week
level of serum free testosterone
Time frame: 4 week
Aging Males' Symptoms (AMS) scale
Time frame: 8 week
level of serum total testosterone
Time frame: 8 week
level of serum free testosterone
Time frame: 8week
7 secondary outcomes
percentage of positivity on the Androgen Deficiency in Aging Males (ADAM) questionnaire
Time frame: 8 week
level of serum total cholesterol
Time frame: 8 week
level of serum HDL-C
Time frame: 8 week
level of serum LDL-C
Time frame: 8 week
level of serum triglyceride
Time frame: 8 week
perceived stress scale (PSS)-10
Time frame: 8 week
Scores of the International Index of Erectile Function (IIEF)
Time frame: 8 week
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 20 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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 Phase 4 study testing TFG capsules (200 mg /capsule) in people with Hypogonadism, run by Pusan National University Hospital at 1 site in South Korea.
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 1 inclusion and 1 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 20 Feb 2017. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Aging Males' Symptoms (AMS) scale (time frame: 4 week). The study lists 6 primary outcomes in all. 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 20 Feb 2017.