HypogonadismPhase 3STEROSENSNCT02847806
Effects of Replacement Therapy With Sexual Steroid Hormones on the Insulin Sensitivity of Hypogonadal Man
A Phase 3 study testing Estradiol (Insulin sensitivity) and Testosterone (Insulin sensitivity) in people with Hypogonadism, run by University Hospital, Caen at 1 site in France.
Trial summary
Sexual steroids administered to supra-physiological doses are likely to change the carbohydrate and lipid metabolism. Investigators propose to study in 12 hypogonadal men hypogonadotropic or hypergonadotropic treated with aromatase inhibitor, the respective effects of estradiol, testosterone or both steroids… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Hypogonadism
- What is being tested?
- Estradiol (Insulin sensitivity) and Testosterone (Insulin sensitivity)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Aug 2016
- Phase
- Phase 3
- 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Hypogonadism hypogonadotropic or hypergonadotropic
- Man aged 18-60 years
- BMI between 18 and 27.
Who cannot join
- Other ante-pituitary deficiency
- Chronic treatment modifying carbohydrate metabolism (thiazides, beta 2 mimetics, steroids ...)
- Diabetes
- Obesity diffuse or android
- Hemochromatosis
- osteoporosis
Show all 9Show fewer
- chronic diseases
- neoplasia
- High blood pressure
Trial locations and contacts
1 site in 1 country.
France1 site
Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen
Caen, 14000
About this study
Sexual steroids administered to supra-physiological doses are likely to change the carbohydrate and lipid metabolism.
Investigators propose to study in 12 hypogonadal men hypogonadotropic or hypergonadotropic treated with aromatase inhibitor, the respective effects of estradiol, testosterone or both steroids administered in a cross-over Latin squares plan on insulin sensitivity measured by the reference method of the hyperinsulinemic euglycemic clamp.
- Conditions
- Hypogonadism
- Being tested
- Estradiol (Insulin sensitivity), Testosterone (Insulin sensitivity)
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol (Insulin sensitivity)Biological
Testosterone (Insulin sensitivity)Biological
| Study group | Role | What they receive |
|---|---|---|
| Estradiol | Experimental | dosage used in the study: 1 patch / 3-4 days dosed at 25, 37.5 or 50 mg / 24h titration according to the plasma level, with the objective of a physiological level of estradiol (25-40 pg / ml ) - During 4 weeks Receives: Biological: Estradiol (Insulin sensitivity) |
| Testosterone | Experimental | dosage used : from 25 to 75 mg / day of testosterone (ie 2.5 to 7.5 g / day transdermal gel) according to the plasma level, with the goal of a physiological level of testosterone (5-8 ng / ml) - During 4 weeks Receives: Biological: Testosterone (Insulin sensitivity) |
| Testosterone + Estradiol | Experimental | Testosterone + Estradiol During 4 weeks Receives: Biological: Estradiol (Insulin sensitivity); Biological: Testosterone (Insulin sensitivity) |
What is being measured
The primary outcome is the main question the study is designed to answer.
GIR (glucose infusion rate) during euglycemic hyperinsulinemic clamp
Measured: change between baseline and after 4 weeks of treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startJan 2008
- Primary completionDec 2015
- Study completionAug 2016
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.
- More trials run by University Hospital, CaenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847806
- Sponsor's protocol ID
- 07-034
- Acronym
- STEROSENS
- Status last verified
- Jul 2016
- First submitted
- 13 Aug 2015
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Replacement Therapy With Sexual Steroid Hormones on the Insulin Sensitivity of Hypogonadal Man
- ClinicalTrials.gov ID
- NCT02847806
- Acronym / sponsor ID
- STEROSENS / 07-034
- Conditions
- Hypogonadism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 28 Jul 2016 (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.
Sexual steroids administered to supra-physiological doses are likely to change the carbohydrate and lipid metabolism.
Investigators propose to study in 12 hypogonadal men hypogonadotropic or hypergonadotropic treated with aromatase inhibitor, the respective effects of estradiol, testosterone or both steroids administered in a cross-over Latin squares plan on insulin sensitivity measured by the reference method of the hyperinsulinemic euglycemic clamp.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Estradiol | Experimental | Biological: Estradiol (Insulin sensitivity)dosage used in the study: 1 patch / 3-4 days dosed at 25, 37.5 or 50 mg / 24h titration according to the plasma level, with the objective of a physiological level of estradiol (25-40 pg / ml ) - During 4 weeks |
| Testosterone | Experimental | Biological: Testosterone (Insulin sensitivity)dosage used : from 25 to 75 mg / day of testosterone (ie 2.5 to 7.5 g / day transdermal gel) according to the plasma level, with the goal of a physiological level of testosterone (5-8 ng / ml) - During 4 weeks |
| Testosterone + Estradiol | Experimental | Biological: Estradiol (Insulin sensitivity), Biological: Testosterone (Insulin sensitivity)Testosterone + Estradiol During 4 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Hypogonadism hypogonadotropic or hypergonadotropic
- Man aged 18-60 years
- BMI between 18 and 27.
Key exclusion criteria (9 listed)
- Other ante-pituitary deficiency
- Chronic treatment modifying carbohydrate metabolism (thiazides, beta 2 mimetics, steroids ...)
- Diabetes
- Obesity diffuse or android
- Hemochromatosis
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 |
|---|---|---|
| Estradiol (Insulin sensitivity) | Biological | Estradiol, Testosterone + Estradiol |
| Testosterone (Insulin sensitivity) | Biological | Testosterone, Testosterone + Estradiol |
Primary outcome
GIR (glucose infusion rate) during euglycemic hyperinsulinemic clamp
Time frame: change between baseline and after 4 weeks of treatments
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 17 Aug 2018.
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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 3 study testing Estradiol (Insulin sensitivity) and Testosterone (Insulin sensitivity) in people with Hypogonadism, run by University Hospital, Caen at 1 site in France.
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 9 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 17 Aug 2018. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
GIR (glucose infusion rate) during euglycemic hyperinsulinemic clamp (time frame: change between baseline and after 4 weeks of treatments). 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 17 Aug 2018.