Trial Outcomes & Findings for Clomiphene Citrate for the Treatment of Low Testosterone Associated With Chronic Opioid Pain Medication Administration (NCT NCT01880086)
NCT ID: NCT01880086
Last Updated: 2018-07-17
Results Overview
Morning venipuncture of serum total testosterone.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
3 months post initial visit
Results posted on
2018-07-17
Participant Flow
Participant milestones
| Measure |
Clomiphene Citrate
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
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 Study
STARTED
|
6
|
7
|
|
Overall Study
COMPLETED
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Clomiphene Citrate
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
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 Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Clomiphene Citrate for the Treatment of Low Testosterone Associated With Chronic Opioid Pain Medication Administration
Baseline characteristics by cohort
| Measure |
Clomiphene Citrate
n=5 Participants
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
n=6 Participants
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
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 months post initial visitMorning venipuncture of serum total testosterone.
Outcome measures
| Measure |
Clomiphene Citrate
n=5 Participants
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
n=6 Participants
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.
|
|---|---|---|
|
Serum Total Testosterone (Change From Baseline)
|
322.5 ng/mL
Standard Deviation 40.9
|
179.8 ng/mL
Standard Deviation 72.2
|
SECONDARY outcome
Timeframe: 3 months post initial visitLuteinizing hormone (LH)
Outcome measures
| Measure |
Clomiphene Citrate
n=5 Participants
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
n=6 Participants
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.
|
|---|---|---|
|
Other Hormonal Profile (Change From Baseline)
|
3.3 IU/mL
Standard Deviation 2.4
|
2.2 IU/mL
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 3 months post initial visitOverall, 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.
Outcome measures
| Measure |
Clomiphene Citrate
n=5 Participants
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
n=6 Participants
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.
|
|---|---|---|
|
Androgen Deficiency in the Aging Male (ADAM) Questionnaire
|
8.0 scores on a scale
Standard Deviation 1.6
|
8.0 scores on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 3 months post initial visitMeasure hematocrit from baseline.
Outcome measures
| Measure |
Clomiphene Citrate
n=5 Participants
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
n=6 Participants
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.
|
|---|---|---|
|
Hematocrit (%)
|
35.2 percentage
Standard Deviation 12.8
|
42.3 percentage
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: 3 months post initial visitOutcome measures
| Measure |
Clomiphene Citrate
n=5 Participants
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
n=6 Participants
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.
|
|---|---|---|
|
Estradiol
|
23 pg/mL
Standard Deviation 4.1
|
25.2 pg/mL
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: 3 months post initial visitOverall, 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.
Outcome measures
| Measure |
Clomiphene Citrate
n=5 Participants
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
n=6 Participants
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.
|
|---|---|---|
|
Sexual Health Inventory for Men (SHIM) Questionnaire
|
12.2 scores on a scale
Standard Deviation 4.0
|
18.5 scores on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: 3 months post initial visitOverall, 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.
Outcome measures
| Measure |
Clomiphene Citrate
n=5 Participants
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
n=6 Participants
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.
|
|---|---|---|
|
Men's Sexual Health Questionnaire (MSHQ) Questionnaire
|
7.0 scores on a scale
Standard Deviation 1.2
|
8.8 scores on a scale
Standard Deviation 4.3
|
Adverse Events
Clomiphene Citrate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place