Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 19 for:    "Hypogonadism" | "Calcium, Dietary"

Clomiphene Citrate for the Treatment of Low Testosterone Associated With Chronic Opioid Pain Medication Administration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01880086
Recruitment Status : Completed
First Posted : June 18, 2013
Results First Posted : June 5, 2017
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Hypogonadism
Opioid-Related Disorders
Male Infertility
Interventions Drug: Clomiphene citrate
Drug: Placebo
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clomiphene Citrate Placebo
Hide Arm/Group Description

The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.

Clomiphene citrate

Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.

Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication.

Period Title: Overall Study
Started 6 7
Completed 5 6
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             1
Arm/Group Title Clomiphene Citrate Placebo Total
Hide Arm/Group Description

The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.

Clomiphene citrate

Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.

Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication.

Total of all reporting groups
Overall Number of Baseline Participants 5 6 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 11 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
6
 100.0%
11
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 11 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
5
 100.0%
6
 100.0%
11
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 11 participants
American Indian or Alaska Native
1
  20.0%
0
   0.0%
1
   9.1%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  40.0%
1
  16.7%
3
  27.3%
White
2
  40.0%
5
  83.3%
7
  63.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Serum Total Testosterone (Change From Baseline)
Hide Description Morning venipuncture of serum total testosterone.
Time Frame 3 months post initial visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clomiphene Citrate Placebo
Hide Arm/Group Description:

The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.

Clomiphene citrate

Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.

Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
322.5  (40.9) 179.8  (72.2)
2.Secondary Outcome
Title Other Hormonal Profile (Change From Baseline)
Hide Description Luteinizing hormone (LH)
Time Frame 3 months post initial visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clomiphene Citrate Placebo
Hide Arm/Group Description:

The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.

Clomiphene citrate

Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.

Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: IU/mL
3.3  (2.4) 2.2  (1.2)
3.Secondary Outcome
Title Androgen Deficiency in the Aging Male (ADAM) Questionnaire
Hide Description Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Minimum score is 0 and maximum score is 10. 0 is most symptomatic, and 10 is least symptomatic.
Time Frame 3 months post initial visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clomiphene Citrate Placebo
Hide Arm/Group Description:

The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.

Clomiphene citrate

Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.

Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: scores on a scale
8.0  (1.6) 8.0  (2.1)
4.Secondary Outcome
Title Hematocrit (%)
Hide Description Measure hematocrit from baseline.
Time Frame 3 months post initial visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clomiphene Citrate Placebo
Hide Arm/Group Description:

The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.

Clomiphene citrate

Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.

Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: percentage
35.2  (12.8) 42.3  (3.5)
5.Secondary Outcome
Title Estradiol
Hide Description [Not Specified]
Time Frame 3 months post initial visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clomiphene Citrate Placebo
Hide Arm/Group Description:

The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.

Clomiphene citrate

Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.

Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: pg/mL
23  (4.1) 25.2  (7.6)
6.Secondary Outcome
Title Sexual Health Inventory for Men (SHIM) Questionnaire
Hide Description Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Minimum score is 1, maximum score is 25. The minimum value is most symptomatic and maximum value is least symptomatic.
Time Frame 3 months post initial visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clomiphene Citrate Placebo
Hide Arm/Group Description:

The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.

Clomiphene citrate

Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.

Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: scores on a scale
12.2  (4.0) 18.5  (5.8)
7.Secondary Outcome
Title Men's Sexual Health Questionnaire (MSHQ) Questionnaire
Hide Description Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Minimum score is 1, maximum score is 20. Minimum score is considered most symptomatic, maximum score is considered least symptomatic.
Time Frame 3 months post initial visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clomiphene Citrate Placebo
Hide Arm/Group Description:

The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.

Clomiphene citrate

Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.

Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: scores on a scale
7.0  (1.2) 8.8  (4.3)
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clomiphene Citrate Placebo
Hide Arm/Group Description

The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.

Clomiphene citrate

Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.

Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication.

All-Cause Mortality
Clomiphene Citrate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/6 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Clomiphene Citrate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clomiphene Citrate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/6 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Peter N. Schlegel
Organization: Weill Cornell Medical College
Phone: 2127465491
EMail: pnschleg@med.cornell.edu
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01880086     History of Changes
Other Study ID Numbers: Cornell-1301013472
First Submitted: June 7, 2013
First Posted: June 18, 2013
Results First Submitted: January 25, 2017
Results First Posted: June 5, 2017
Last Update Posted: July 17, 2018