Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03118479
Other study ID # 2009 - P - 001874
Secondary ID
Status Terminated
Phase Phase 1
First received July 14, 2010
Last updated April 17, 2017
Start date May 2010
Est. completion date September 1, 2010

Study information

Verified date April 2017
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators are doing this research study to look at the relationship between testosterone (the main sex hormone in men) and insulin (the hormone that controls blood sugar levels) in men with Idiopathic Hypogonadotropic Hypogonadism (IHH).

The investigators hypothesize that normalizing testosterone levels in men with IHH enhances insulin sensitivity, reduces visceral fat, increases lean body mass, and improves the lipid profile.


Recruitment information / eligibility

Status Terminated
Enrollment 7
Est. completion date September 1, 2010
Est. primary completion date September 1, 2010
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of idiopathic hypogonadotropic hypogonadism or Kallmann Syndrome

- mean testosterone level less than 300 ng/dl

- stable weight for the previous 3 months (no weight change greater than or equal to 10 lbs)

- normal serum TSH

- normal serum prolactin levels

Exclusion Criteria:

- Type 2 diabetes mellitus

- history of diabetes in parents

- sleep apnea

- bleeding disorder

- seeking fertility

- 2 or more cardiovascular risk factors: smoking, hypertension, diabetes, dyslipidemias, family history of cardiovascular disease before age 60.

- history of previous cardiovascular event: myocardial infarction, unstable angina, cerebro-vascular accident.

- illicit drug use/alcohol use (>4 drinks per day)

Study Design


Intervention

Drug:
Anastrozole Pill
10 mg of Anastrozole to be taken daily for 3 months.
Testosterone
Androgel 7.5 g to be applied transdermally daily for 3 months.
Placebo Oral Tablet
One tablet to be taken daily for 3 months

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in glucose tolerance Response to 75 g glucose load Change between baseline and 3 months
Primary Change in insulin sensitivity IV glucose tolerance test Change between baseline and 3 months
Secondary Change in visceral fat Assessed by CT of abdomen Change between baseline and 3 months
Secondary Change in resting energy expenditure Assessed by metabolic monitor Change between baseline and 3 months
See also
  Status Clinical Trial Phase
Completed NCT01438073 - Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling Phase 1
Completed NCT01403532 - Sequential Therapy for Hypogonadotropic Hypogonadism Phase 4
Recruiting NCT00456274 - Baselines in Reproductive Disorders N/A
Terminated NCT05205837 - A Randomized, Double-blinded, Clinical, Placebo-controlled Trial on the Effects of Therapy With Letrozole and hUman Choriongonadotropin in Male Hypogonadism Induced by Illicit Use of Anabolic Androgenic Steroids- The LUCAS Trial Phase 4
Completed NCT02908074 - A 6 Month Safety Extension Study of MBGS205 Phase 2
Completed NCT05752591 - Hypothalamic-pituitary Dysfunction in Diabetes
Completed NCT02730169 - Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism Phase 2
Completed NCT02110368 - Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions Phase 3
Recruiting NCT01601171 - Genetics of Reproductive Disorders (Including Kallmann Syndrome) and Cleft Lip and/or Palate
Completed NCT01623570 - Clinical Outcomes in WHO Type I Anovulatory Women Using r-hFSH+r-hLH in a 2:1 Ratio or hMG-HP N/A
Terminated NCT00328926 - Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L]) Phase 4
Completed NCT01438034 - Kisspeptin in the Evaluation of Delayed Puberty Phase 1
Completed NCT04456296 - A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism Phase 4
Recruiting NCT00914823 - Kisspeptin Administration in the Adult Phase 1
Terminated NCT01155518 - Hypogonadism in Young Men With Type 2 Diabetes Phase 2
Completed NCT00697814 - Clomiphene in Males With Prolactinomas and Persistent Hypogonadism Phase 2
Active, not recruiting NCT00351416 - Letrozole Treatment in Normal and GnRH Deficient Women Phase 2/Phase 3
Recruiting NCT05971836 - The Molecular Basis of Inherited Reproductive Disorders
Recruiting NCT02705014 - Efficacy of Pulsatile GnRH Therapy on Male Patients With Pituitary Stalk Interruption Syndrome N/A
Recruiting NCT04648969 - Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism Phase 2