Trial Outcomes & Findings for Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism (NCT NCT01534208)
NCT ID: NCT01534208
Last Updated: 2014-07-24
Results Overview
Changes in values from baseline of total morning testosterone levels at Week 26
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
499 participants
Primary outcome timeframe
6 months
Results posted on
2014-07-24
Participant Flow
Participant milestones
| Measure |
Androxal 12.5 mg
Androxal 12.5 mg daily
Androxal, oral, 12.5 mg capsule, taken once daily
|
Androxal 25 mg
Androxal 25 mg daily
Androxal, oral, 25 mg capsule, taken once daily
|
|---|---|---|
|
Overall Study
STARTED
|
216
|
283
|
|
Overall Study
COMPLETED
|
159
|
234
|
|
Overall Study
NOT COMPLETED
|
57
|
49
|
Reasons for withdrawal
| Measure |
Androxal 12.5 mg
Androxal 12.5 mg daily
Androxal, oral, 12.5 mg capsule, taken once daily
|
Androxal 25 mg
Androxal 25 mg daily
Androxal, oral, 25 mg capsule, taken once daily
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
19
|
14
|
|
Overall Study
Withdrawal by Subject
|
6
|
20
|
|
Overall Study
Adverse Event
|
15
|
8
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
3
|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
Sponsor decision
|
4
|
1
|
|
Overall Study
Subject relocation
|
2
|
0
|
|
Overall Study
Lab assessment
|
2
|
1
|
|
Overall Study
Eligibility error
|
3
|
0
|
|
Overall Study
PCP decision
|
1
|
0
|
|
Overall Study
Needed prohibited meds
|
1
|
0
|
Baseline Characteristics
Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
Baseline characteristics by cohort
| Measure |
Androxal 12.5 mg
n=216 Participants
Androxal 12.5 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
|
Androxal 25 mg
n=283 Participants
Androxal 25 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
|
Total
n=499 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
49.5 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
48.6 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
216 Participants
n=5 Participants
|
283 Participants
n=7 Participants
|
499 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
216 participants
n=5 Participants
|
283 participants
n=7 Participants
|
499 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Intent to Treat population
Changes in values from baseline of total morning testosterone levels at Week 26
Outcome measures
| Measure |
Androxal 12.5 mg
n=168 Participants
Androxal 12.5 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
|
Androxal 25 mg
n=242 Participants
Androxal 25 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
|
|---|---|---|
|
Change From Baseline in Total Morning Testosterone at 26 Weeks
|
280.9 ng/dL
Standard Deviation 141.4
|
214.7 ng/dL
Standard Deviation 154.7
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: ITT
Mean change from baseline in LH at end of treatment (26 weeks)
Outcome measures
| Measure |
Androxal 12.5 mg
n=168 Participants
Androxal 12.5 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
|
Androxal 25 mg
n=242 Participants
Androxal 25 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
|
|---|---|---|
|
Change From Baseline in LH
|
4.81 mIu/mL
Standard Deviation 5.69
|
4.27 mIu/mL
Standard Deviation 4.29
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: ITT
Absolute values of morning testosterone at end of treatment (26 weeks)
Outcome measures
| Measure |
Androxal 12.5 mg
n=216 Participants
Androxal 12.5 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
|
Androxal 25 mg
n=283 Participants
Androxal 25 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
|
|---|---|---|
|
Absolute Values of Morning Testosterone
|
511.6 ng/dL
Standard Deviation 140.8
|
416.7 ng/dL
Standard Deviation 154.7
|
PRIMARY outcome
Timeframe: 6 monthsMean changes in Fasting Plasma Glucose from baseline to end of treatment (26 weeks)
Outcome measures
| Measure |
Androxal 12.5 mg
n=168 Participants
Androxal 12.5 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
|
Androxal 25 mg
n=242 Participants
Androxal 25 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
|
|---|---|---|
|
Mean Change From Baseline FPG
|
-5.4 mg/dL
Standard Deviation 30.8
|
-5.0 mg/dL
Standard Deviation 29.3
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: ITT
Mean change from baseline in BMI at end of treatment (26 weeks)
Outcome measures
| Measure |
Androxal 12.5 mg
n=216 Participants
Androxal 12.5 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
|
Androxal 25 mg
n=283 Participants
Androxal 25 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
|
|---|---|---|
|
Change From Baseline in BMI
|
0.2 kg/m2
Standard Deviation 1.4
|
0.3 kg/m2
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: 6 monthsChange from baseline in FSH at end of treatment (26 weeks)
Outcome measures
| Measure |
Androxal 12.5 mg
n=168 Participants
Androxal 12.5 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
|
Androxal 25 mg
n=242 Participants
Androxal 25 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
|
|---|---|---|
|
Change From Baseline in FSH
|
5.20 U/L
Standard Deviation 5.19
|
5.42 U/L
Standard Deviation 5.48
|
Adverse Events
Androxal 12.5 mg
Serious events: 6 serious events
Other events: 66 other events
Deaths: 0 deaths
Androxal 25 mg
Serious events: 9 serious events
Other events: 92 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Androxal 12.5 mg
n=207 participants at risk
Androxal 12.5 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
|
Androxal 25 mg
n=283 participants at risk
Androxal 25 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
|
|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/207 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
0.35%
1/283 • Number of events 1 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
|
Cardiac disorders
Bradycardia
|
0.48%
1/207 • Number of events 1 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
0.00%
0/283 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
|
General disorders
Chest pain
|
0.48%
1/207 • Number of events 1 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
0.00%
0/283 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
|
Hepatobiliary disorders
Biliary colic
|
0.48%
1/207 • Number of events 1 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
0.00%
0/283 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/207 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
0.35%
1/283 • Number of events 1 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/207 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
0.71%
2/283 • Number of events 2 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
|
Injury, poisoning and procedural complications
Food poisoning
|
0.00%
0/207 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
0.35%
1/283 • Number of events 1 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
|
Nervous system disorders
Transient ischemic attack
|
0.48%
1/207 • Number of events 1 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
0.00%
0/283 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
|
Renal and urinary disorders
Kidney infection
|
0.00%
0/207 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
0.35%
1/283 • Number of events 1 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
|
Reproductive system and breast disorders
Seminoma
|
0.48%
1/207 • Number of events 1 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
0.00%
0/283 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.48%
1/207 • Number of events 1 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
0.00%
0/283 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/207 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
0.35%
1/283 • Number of events 1 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/207 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
0.71%
2/283 • Number of events 2 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
|
Surgical and medical procedures
Knee arthroplasy
|
0.48%
1/207 • Number of events 1 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
0.00%
0/283 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
|
Vascular disorders
Deep vein thrombosis
|
0.48%
1/207 • Number of events 1 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
0.35%
1/283 • Number of events 1 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
|
Vascular disorders
Hypotension
|
0.48%
1/207 • Number of events 1 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
0.00%
0/283 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
Other adverse events
| Measure |
Androxal 12.5 mg
n=207 participants at risk
Androxal 12.5 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
|
Androxal 25 mg
n=283 participants at risk
Androxal 25 mg daily
Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
12.6%
26/207 • Number of events 26 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
9.5%
27/283 • Number of events 27 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
|
Nervous system disorders
Headache
|
5.8%
12/207 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
8.1%
23/283 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
|
General disorders
Hot flush
|
0.97%
2/207 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
3.2%
9/283 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
|
Infections and infestations
Influenza
|
3.4%
7/207 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
1.8%
5/283 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
|
Infections and infestations
Sinusitis
|
3.4%
7/207 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
2.1%
6/283 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.8%
10/207 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
4.2%
12/283 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
|
Nervous system disorders
Dizziness
|
2.9%
6/207 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
1.8%
5/283 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
|
Renal and urinary disorders
Pollakiuria
|
2.9%
6/207 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
1.8%
5/283 • From first administration of study drug until 8 weeks after end of treatment (8 months total)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to publication, Investigator shall submit to the Sponsor a copy of any proposed publication. Sponsor shall have sixty (60) days to review the proposed publication for possible disclosure of Sponsor's Confidential Information and, upon request of Sponsor, Investigator shall delete any of Sponsor's Confidential Information or withhold submission of such publication to allow Sponsor to protect its intellectual property rights
- Publication restrictions are in place
Restriction type: OTHER