ObesityPhase 2NCT02380755
Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism
A Phase 2 study testing Clomiphene Citrate in people with Obesity and Hypoandrogenism, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Hypogonadism is a clinical condition that can be associated with obesity in man. Controversy exists regarding if its a condition that needs to be treated. The standard Testosterone Therapy is associated with increase in cardiovascular risks, according to some studies, and leads to infertility. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Obesity, Hypoandrogenism
- What is being tested?
- Clomiphene Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2015to Jan 2017
- Phase
- Phase 2
- 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 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- ADAM questionnaire positive for 3 or more questions
- Total serum Testosterone lower than 300 ng/dL in two different occasions, within a 1-week minimum interval. This blood sample must be collected between 8 and 11 a.m.
- Low or Inappropriate normal serum Luteinizing hormone (LH) level
- ATP III Metabolic Syndrome Criteria
- Obesity - BMI over 30 kg/m2
Who cannot join
- Systemic illness, such Rheumatoid Arthritis, Cushing disease, liver insufficiency or renal insufficiency. -Use of certain medications (opiates, high-dose glucocorticoid therapy, methadone)
- Eating disorders
- Testicular volume below 4 mL
- Use of recreational drugs
- Excessive exercise practice
- Men in treatment for prostatic cancer
Show all 12Show fewer
- Hyperprolactinaemia
- Hemochromatosis
- History of headache
- Systolic blood pressure lower than 100 mmHg
- Previous adverse reactions to nitrate compounds
- Diabetes over 10 years of diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism: Metabolic and Cardiovascular Effects.
Hypogonadism is a clinical condition that can be associated with obesity in man. Controversy exists regarding if its a condition that needs to be treated. The standard Testosterone Therapy is associated with increase in cardiovascular risks, according to some studies, and leads to infertility. The use of Clomiphene Citrate in this sub population of obese man as an alternative treatment option is not well studied. The aim of this protocol is to evaluate the cardiovascular risks, metabolic and hormonal parameters in a double blinded randomized placebo trial.
Read the detailed description
Hypogonadism (low testosterone level) in obese man is a clinical condition which treatment is controversial. Most of this controversy remains regarding the association between cardiovascular risk elevation and Testosterone replacement therapy in some studies.
This protocol is a double blinded randomized placebo trial and 2 groups will be followed. The primary end-point of this research is the correlation between the serum testosterone and flow-mediated dilatation of the brachial artery (FMDAB), circulating levels of sICAM-1, sVCAM-1, E-selectin and progenitor endothelial cells.
The secondary end-points include:
(1) the evaluation of metabolic parameters: weight, abdominal circumference, glycaemia, total cholesterol, fractions and triglycerides, homeostasis model assessment index (HOMA) and bioelectrical impedance parameters; and (2) hormonal parameters: total testosterone levels, sex hormone-binding globulin (SHBG), Luteinizing Hormone (LH) , Follicle stimulating hormone (FSH) and Estradiol.
- Conditions
- Obesity, Hypoandrogenism
- Being tested
- Clomiphene Citrate, Placebo
- Keywords
- Flow-mediated dilatation, Clomiphene citrate, sICAM-1, sVCAM-1, sE- Selectin, Endothelial function, Cardiovascular risk, Endocrine System Diseases, Selective Estrogen Receptor Modulators, Estrogen Receptor Modulators, Infertility, Male, Endothelial Progenitor Cells, Obesity, Testosterone
- Medical subject headings
- Obesity, Endocrine System Diseases, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomiphene CitrateDrug
Also called Serophene
50 mg orally daily during 12 weeks
PlaceboDrug
Also called Control
1 pill orally daily during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | One pill every other day during 12 weeks Receives: Drug: Placebo |
| Clomiphene Citrate | Active comparator | Clomiphene citrate 50 mg orally daily (Serophene) during 12 weeks Receives: Drug: Clomiphene Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Function
- Flow-mediated dilatation of the brachial artery (FMDAB): Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter.
- Icam, vcam and selectin
- Endothelial progenitor cels
Measured: baseline up to 12 weeks
Total Testosterone
electrochemical luminescence analysis in blood sample
Measured: baseline up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 78 patients were randomized (1:1) to receive Clomiphene Citrate (CC) 50 mg during 12 weeks or placebo (PLB). MAIN OUTCOME MEASURES: flow-mediated dilatation of the brachial artery (FMDAB), circulating levels of sICAM-1, sVCAM-1, E-selectin and progenitor endothelial cells. Secondary endpoints: Body mass index (BMI), abdominal circumference (AC), glycaemia, total cholesterol, fractions and triglycerides, HOMA-IR index, bioelectrical impedance parameters, Adam questionnaire and hormonal parameters (total testosterone levels, SHBG, LH, FSH and Estradiol).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Cintia Cercato, University of Sao Paulo
- Investigators
- Cintia Cercato, MD, Principal investigator, University of Sao PauloElaine Maria F Costa, Prof, PhD, Principal investigator, Faculdade de Medicina da USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380755
- Sponsor's protocol ID
- 385.615
- Other IDs
- 2013/16781-1
- Status last verified
- Dec 2017
- First submitted
- 1 Mar 2015
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism: Metabolic and Cardiovascular Effects.
- ClinicalTrials.gov ID
- NCT02380755
- Acronym / sponsor ID
- 385.615
- Conditions
- Obesity, Hypoandrogenism
- Keywords
- Flow-mediated dilatation, Clomiphene citrate, sICAM-1, sVCAM-1, sE- Selectin, Endothelial function, Cardiovascular risk, Endocrine System Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Apr 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 5 Mar 2015 (estimated)
- 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.
Hypogonadism is a clinical condition that can be associated with obesity in man. Controversy exists regarding if its a condition that needs to be treated. The standard Testosterone Therapy is associated with increase in cardiovascular risks, according to some studies, and leads to infertility. The use of Clomiphene Citrate in this sub population of obese man as an alternative treatment option is not well studied. The aim of this protocol is to evaluate the cardiovascular risks, metabolic and hormonal parameters in a double blinded randomized placebo trial.
Detailed description
Hypogonadism (low testosterone level) in obese man is a clinical condition which treatment is controversial. Most of this controversy remains regarding the association between cardiovascular risk elevation and Testosterone replacement therapy in some studies.
This protocol is a double blinded randomized placebo trial and 2 groups will be followed. The primary end-point of this research is the correlation between the serum testosterone and flow-mediated dilatation of the brachial artery (FMDAB), circulating levels of sICAM-1, sVCAM-1, E-selectin and progenitor endothelial cells.
The secondary end-points include:
(1) the evaluation of metabolic parameters: weight, abdominal circumference, glycaemia, total cholesterol, fractions and triglycerides, homeostasis model assessment index (HOMA) and bioelectrical impedance parameters; and (2) hormonal parameters: total testosterone levels, sex hormone-binding globulin (SHBG), Luteinizing Hormone (LH) , Follicle stimulating hormone (FSH) and Estradiol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 78 patients were randomized (1:1) to receive Clomiphene Citrate (CC) 50 mg during 12 weeks or placebo (PLB). MAIN OUTCOME MEASURES: flow-mediated dilatation of the brachial artery (FMDAB), circulating levels of sICAM-1, sVCAM-1, E-selectin and progenitor endothelial cells. Secondary endpoints: Body mass index (BMI), abdominal circumference (AC), glycaemia, total cholesterol, fractions and triglycerides, HOMA-IR index, bioelectrical impedance parameters, Adam questionnaire and hormonal parameters (total testosterone levels, SHBG, LH, FSH and Estradiol).
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboOne pill every other day during 12 weeks |
| Clomiphene Citrate | Active comparator | Drug: Clomiphene CitrateClomiphene citrate 50 mg orally daily (Serophene) during 12 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ADAM questionnaire positive for 3 or more questions
- Total serum Testosterone lower than 300 ng/dL in two different occasions, within a 1-week minimum interval. This blood sample must be collected between 8 and 11 a.m.
- Low or Inappropriate normal serum Luteinizing hormone (LH) level
- ATP III Metabolic Syndrome Criteria
- Obesity - BMI over 30 kg/m2
Key exclusion criteria (12 listed)
- Systemic illness, such Rheumatoid Arthritis, Cushing disease, liver insufficiency or renal insufficiency. -Use of certain medications (opiates, high-dose glucocorticoid therapy, methadone)
- Eating disorders
- Testicular volume below 4 mL
- Use of recreational drugs
- Excessive exercise practice
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 |
|---|---|---|
| Clomiphene CitrateAlso: Serophene50 mg orally daily during 12 weeks | Drug | Clomiphene Citrate |
| PlaceboAlso: Control1 pill orally daily during 12 weeks | Drug | Placebo |
Primary outcome
Endothelial Function
Time frame: baseline up to 12 weeks
1. Flow-mediated dilatation of the brachial artery (FMDAB): Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter. 2. Icam, vcam and selectin 3. Endothelial progenitor cels
Total Testosterone
Time frame: baseline up to 12 weeks
electrochemical luminescence analysis in blood sample
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 27 Dec 2017.
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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.
Cintia Cercato, MD principal investigator
University of Sao Paulo
Elaine Maria F Costa, Prof, PhD principal investigator
Faculdade de Medicina da USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clomiphene Citrate in people with Obesity and Hypoandrogenism, run by University of Sao Paulo at 1 site in Brazil.
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 5 inclusion and 12 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 27 Dec 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 Brazil. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Endothelial Function (time frame: baseline up to 12 weeks). The study lists 2 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 27 Dec 2017.