Secondary Hypogonadism
Conditions
Brief summary
The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (\<350 ng/dL)after 6 weeks of continuous dosing.
Detailed description
Study will require 7 visits, which includes 2 overnight stays in a clinic. One visit is an eye exam. Blood samples are required at all visits including sampling every hour for a 24 hour time period during the 2 overnight stays. A six month extension study will be available for all subjects completing the 6-week study.
Interventions
capsule oral 1X a day 6 weeks
DRUGTestosterone
topical gel 1X a day 6 weeks
Sponsors
Repros Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Healthy males between the ages of 18 and 65 years of age exhibiting morning testosterone ≤350 ng/dL. * All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor) * Ability to complete the study in compliance with the protocol * Ability to understand and provide written informed consent * Agreement to use a condom, and with a fertile female partner, another form of contraception. * Agreement to provide a semen sample in the clinic
Exclusion criteria
* Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 3 months prior to study * Use of spironolactone, cimetidine, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study * Use of Clomid in the past year or during the study * Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes but exhibiting glycemic control will be allowed into the study. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in the study. * A hematocrit ≥51 % or a hemoglobin ≥17 g/dL * Clinically significant abnormal findings on screening examination * Use of an investigational drug or product, or participation in a drug or medical device research study within 30 days prior to receiving study medication * Known hypersensitivity to Clomid * Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he took part in the study * Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, vasectomy, or tumors of the pituitary) * History of breast cancer * History of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA \>3.6 * History of known hyperprolactinemia with or without a tumor * Chronic use of medications use such as glucocorticoids * Chronic use of narcotics * Subjects known to be positive for HIV * Subjects with end stage renal disease * Subjects with cystic fibrosis (mutation of the CFTR gene) * Subjects unable to provide a semen sample in the clinic * Subject has a BMI \>42 kg/m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24 Hour Average and Maximum Testosterone Concentration | Baseline and Week 6 | The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment. Time points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Leuteinizing Hormone (LH) | Baseline, Week 2, Week 4, Week 6 | Changes in morning LH after continuous dosing |
| Change in Follicle Stimulating Hormone (FSH) | Baseline, Week 2, Week 4, Week 6 | Changes in morning FSH after continuous dosing |
Other
| Measure | Time frame | Description |
|---|---|---|
| Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax. | Week 6 | The Cmax for plasma concentration. |
| Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax. | Week 6 | The Tmax for plasma concentration. |
| Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24. | Week 6 | The area under the curve for plasma concentration over time from zero to 24 hours (AUC0-24). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Androxal 6.25 mg enclomiphene citrate: capsule oral
1X a day 6 weeks | 16 |
| Androxal 12.5 mg enclomiphene citrate: capsule oral
1X a day 6 weeks | 14 |
| Androxal 25 mg enclomiphene citrate: capsule oral
1X a day 6 weeks | 16 |
| AndroGel AndroGel 5G topical testosterone
Testosterone: topical gel
1X a day 6 weeks | 14 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 2 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 1 | 1 |
| Overall Study | Subject incarcerated | 0 | 1 | 0 | 0 |
| Overall Study | T levels too high | 0 | 1 | 1 | 0 |
| Overall Study | Unable to draw PK | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Androxal 6.25 mg | Androxal 12.5 mg | Androxal 25 mg | AndroGel | Total |
|---|---|---|---|---|---|
| Age, Continuous | 53.4 years STANDARD_DEVIATION 8.8 | 51.7 years STANDARD_DEVIATION 9.2 | 51.8 years STANDARD_DEVIATION 13 | 53.5 years STANDARD_DEVIATION 9.8 | 52.6 years STANDARD_DEVIATION 10.2 |
| BMI | 33.3 Kg/m^2 STANDARD_DEVIATION 5.9 | 31.2 Kg/m^2 STANDARD_DEVIATION 6.6 | 31.6 Kg/m^2 STANDARD_DEVIATION 6.3 | 31.0 Kg/m^2 STANDARD_DEVIATION 6.1 | 31.8 Kg/m^2 STANDARD_DEVIATION 6.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 8 Participants | 10 Participants | 2 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 6 Participants | 6 Participants | 12 Participants | 32 Participants |
| Region of Enrollment United States | 16 participants | 14 participants | 16 participants | 14 participants | 60 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 16 Participants | 14 Participants | 16 Participants | 14 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 16 | 1 / 14 | 1 / 16 | 4 / 14 |
| serious Total, serious adverse events | 0 / 16 | 0 / 14 | 0 / 16 | 0 / 14 |
Outcome results
Primary
24 Hour Average and Maximum Testosterone Concentration
The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment. Time points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24.
Time frame: Baseline and Week 6
Population: ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Androxal 6.25 mg | 24 Hour Average and Maximum Testosterone Concentration | TTavg at Baseline | 262.3 ng/dL | Standard Deviation 80.3 |
| Androxal 6.25 mg | 24 Hour Average and Maximum Testosterone Concentration | TTavg at Week 6 | 392.4 ng/dL | Standard Deviation 152.6 |
| Androxal 6.25 mg | 24 Hour Average and Maximum Testosterone Concentration | TTmax at Baseline | 358.5 ng/dL | Standard Deviation 120.5 |
| Androxal 6.25 mg | 24 Hour Average and Maximum Testosterone Concentration | TTmax at Week 6 | 524.5 ng/dL | Standard Deviation 178.7 |
| Androxal 12.5 mg | 24 Hour Average and Maximum Testosterone Concentration | TTavg at Week 6 | 460.8 ng/dL | Standard Deviation 129.1 |
| Androxal 12.5 mg | 24 Hour Average and Maximum Testosterone Concentration | TTmax at Baseline | 513.7 ng/dL | Standard Deviation 222.2 |
| Androxal 12.5 mg | 24 Hour Average and Maximum Testosterone Concentration | TTmax at Week 6 | 607.5 ng/dL | Standard Deviation 167.7 |
| Androxal 12.5 mg | 24 Hour Average and Maximum Testosterone Concentration | TTavg at Baseline | 373.6 ng/dL | Standard Deviation 172.1 |
| Androxal 25 mg | 24 Hour Average and Maximum Testosterone Concentration | TTmax at Baseline | 425.9 ng/dL | Standard Deviation 114.3 |
| Androxal 25 mg | 24 Hour Average and Maximum Testosterone Concentration | TTavg at Week 6 | 586.7 ng/dL | Standard Deviation 142.4 |
| Androxal 25 mg | 24 Hour Average and Maximum Testosterone Concentration | TTmax at Week 6 | 764.3 ng/dL | Standard Deviation 158.7 |
| Androxal 25 mg | 24 Hour Average and Maximum Testosterone Concentration | TTavg at Baseline | 298.3 ng/dL | Standard Deviation 100.5 |
| AndroGel | 24 Hour Average and Maximum Testosterone Concentration | TTmax at Week 6 | 930.1 ng/dL | Standard Deviation 550.4 |
| AndroGel | 24 Hour Average and Maximum Testosterone Concentration | TTavg at Week 6 | 543.9 ng/dL | Standard Deviation 229.8 |
| AndroGel | 24 Hour Average and Maximum Testosterone Concentration | TTavg at Baseline | 322.4 ng/dL | Standard Deviation 102.9 |
| AndroGel | 24 Hour Average and Maximum Testosterone Concentration | TTmax at Baseline | 562.3 ng/dL | Standard Deviation 488.5 |
Comparison: Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group.p-value: 0.056Regression, Linear
Comparison: Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group.p-value: 0.43695% CI: [-143.5, 51.98]Regression, Linear
Comparison: Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group.p-value: 0.06895% CI: [-210.6, -11.23]Regression, Linear
Comparison: Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group.p-value: 0.01195% CI: [-242.9, -54.05]Regression, Linear
Comparison: Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group.p-value: <0.00195% CI: [0.37, 0.79]Regression, Linear
Secondary
Change in Follicle Stimulating Hormone (FSH)
Changes in morning FSH after continuous dosing
Time frame: Baseline, Week 2, Week 4, Week 6
Population: ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Androxal 6.25 mg | Change in Follicle Stimulating Hormone (FSH) | Morning FSH at Baseline | 4.61 mIU/mL | Standard Deviation 1.97 |
| Androxal 6.25 mg | Change in Follicle Stimulating Hormone (FSH) | Morning FSH at Week 6 | 5.69 mIU/mL | Standard Deviation 3.34 |
| Androxal 6.25 mg | Change in Follicle Stimulating Hormone (FSH) | Morning FSH Change from Baseline at Week 4 | 1.66 mIU/mL | Standard Deviation 1.94 |
| Androxal 6.25 mg | Change in Follicle Stimulating Hormone (FSH) | Morning FSH at Week 2 | 6.18 mIU/mL | Standard Deviation 2.56 |
| Androxal 6.25 mg | Change in Follicle Stimulating Hormone (FSH) | Morning FSH Change from Baseline at Week 6 | 1.42 mIU/mL | Standard Deviation 2.53 |
| Androxal 6.25 mg | Change in Follicle Stimulating Hormone (FSH) | Morning FSH Change from Baseline at Week 2 | 1.60 mIU/mL | Standard Deviation 1.73 |
| Androxal 6.25 mg | Change in Follicle Stimulating Hormone (FSH) | Morning FSH at Week 4 | 6.45 mIU/mL | Standard Deviation 2.7 |
| Androxal 12.5 mg | Change in Follicle Stimulating Hormone (FSH) | Morning FSH at Week 6 | 8.19 mIU/mL | Standard Deviation 3.25 |
| Androxal 12.5 mg | Change in Follicle Stimulating Hormone (FSH) | Morning FSH at Week 4 | 7.12 mIU/mL | Standard Deviation 2.66 |
| Androxal 12.5 mg | Change in Follicle Stimulating Hormone (FSH) | Morning FSH Change from Baseline at Week 2 | 2.14 mIU/mL | Standard Deviation 2.15 |
| Androxal 12.5 mg | Change in Follicle Stimulating Hormone (FSH) | Morning FSH Change from Baseline at Week 4 | 1.48 mIU/mL | Standard Deviation 2.58 |
| Androxal 12.5 mg | Change in Follicle Stimulating Hormone (FSH) | Morning FSH Change from Baseline at Week 6 | 2.56 mIU/mL | Standard Deviation 2.53 |
| Androxal 12.5 mg | Change in Follicle Stimulating Hormone (FSH) | Morning FSH at Week 2 | 7.77 mIU/mL | Standard Deviation 3.03 |
| Androxal 12.5 mg | Change in Follicle Stimulating Hormone (FSH) | Morning FSH at Baseline | 5.63 mIU/mL | Standard Deviation 2.26 |
| Androxal 25 mg | Change in Follicle Stimulating Hormone (FSH) | Morning FSH at Week 4 | 12.34 mIU/mL | Standard Deviation 9.59 |
| Androxal 25 mg | Change in Follicle Stimulating Hormone (FSH) | Morning FSH at Baseline | 6.31 mIU/mL | Standard Deviation 4.28 |
| Androxal 25 mg | Change in Follicle Stimulating Hormone (FSH) | Morning FSH at Week 2 | 11.41 mIU/mL | Standard Deviation 8.19 |
| Androxal 25 mg | Change in Follicle Stimulating Hormone (FSH) | Morning FSH Change from Baseline at Week 2 | 5.09 mIU/mL | Standard Deviation 4.32 |
| Androxal 25 mg | Change in Follicle Stimulating Hormone (FSH) | Morning FSH Change from Baseline at Week 4 | 6.03 mIU/mL | Standard Deviation 5.9 |
| Androxal 25 mg | Change in Follicle Stimulating Hormone (FSH) | Morning FSH at Week 6 | 13.45 mIU/mL | Standard Deviation 10.84 |
| Androxal 25 mg | Change in Follicle Stimulating Hormone (FSH) | Morning FSH Change from Baseline at Week 6 | 7.14 mIU/mL | Standard Deviation 7.19 |
| AndroGel | Change in Follicle Stimulating Hormone (FSH) | Morning FSH Change from Baseline at Week 2 | -2.58 mIU/mL | Standard Deviation 1.84 |
| AndroGel | Change in Follicle Stimulating Hormone (FSH) | Morning FSH Change from Baseline at Week 6 | -3.03 mIU/mL | Standard Deviation 2.21 |
| AndroGel | Change in Follicle Stimulating Hormone (FSH) | Morning FSH at Week 6 | 3.35 mIU/mL | Standard Deviation 3.34 |
| AndroGel | Change in Follicle Stimulating Hormone (FSH) | Morning FSH at Week 2 | 3.80 mIU/mL | Standard Deviation 3.06 |
| AndroGel | Change in Follicle Stimulating Hormone (FSH) | Morning FSH at Baseline | 6.38 mIU/mL | Standard Deviation 2.79 |
| AndroGel | Change in Follicle Stimulating Hormone (FSH) | Morning FSH Change from Baseline at Week 4 | -2.66 mIU/mL | Standard Deviation 2.2 |
| AndroGel | Change in Follicle Stimulating Hormone (FSH) | Morning FSH at Week 4 | 3.72 mIU/mL | Standard Deviation 3.66 |
Comparison: ANOVA results - change from baseline in morning FSH at Week 2. Modeling change from baseline by treatment group.p-value: <0.001ANOVA
Comparison: ANOVA results - change from baseline in morning FSH at Week 4. Modeling change from baseline by treatment group.p-value: <0.001ANOVA
Comparison: ANOVA results - change from baseline in morning FSH at Week 6. Modeling change from baseline by treatment group.p-value: <0.001ANOVA
Secondary
Change in Leuteinizing Hormone (LH)
Changes in morning LH after continuous dosing
Time frame: Baseline, Week 2, Week 4, Week 6
Population: ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Androxal 6.25 mg | Change in Leuteinizing Hormone (LH) | Morning LH at Baseline | 3.63 mIU/mL | Standard Deviation 1.55 |
| Androxal 6.25 mg | Change in Leuteinizing Hormone (LH) | Morning LH at Week 6 | 6.1 mIU/mL | Standard Deviation 3.3 |
| Androxal 6.25 mg | Change in Leuteinizing Hormone (LH) | Morning LH Change from Baseline at Week 4 | 3.43 mIU/mL | Standard Deviation 3.2 |
| Androxal 6.25 mg | Change in Leuteinizing Hormone (LH) | Morning LH at Week 2 | 5.49 mIU/mL | Standard Deviation 2.69 |
| Androxal 6.25 mg | Change in Leuteinizing Hormone (LH) | Morning LH Change from Baseline at Week 6 | 2.60 mIU/mL | Standard Deviation 3.32 |
| Androxal 6.25 mg | Change in Leuteinizing Hormone (LH) | Morning LH Change from Baseline at Week 2 | 1.99 mIU/mL | Standard Deviation 2.38 |
| Androxal 6.25 mg | Change in Leuteinizing Hormone (LH) | Morning LH at Week 4 | 6.92 mIU/mL | Standard Deviation 3.59 |
| Androxal 12.5 mg | Change in Leuteinizing Hormone (LH) | Morning LH at Week 6 | 8.2 mIU/mL | Standard Deviation 3.3 |
| Androxal 12.5 mg | Change in Leuteinizing Hormone (LH) | Morning LH at Week 4 | 7.20 mIU/mL | Standard Deviation 2.97 |
| Androxal 12.5 mg | Change in Leuteinizing Hormone (LH) | Morning LH Change from Baseline at Week 2 | 3.78 mIU/mL | Standard Deviation 3.29 |
| Androxal 12.5 mg | Change in Leuteinizing Hormone (LH) | Morning LH Change from Baseline at Week 4 | 2.38 mIU/mL | Standard Deviation 3.54 |
| Androxal 12.5 mg | Change in Leuteinizing Hormone (LH) | Morning LH Change from Baseline at Week 6 | 3.39 mIU/mL | Standard Deviation 3.37 |
| Androxal 12.5 mg | Change in Leuteinizing Hormone (LH) | Morning LH at Week 2 | 8.60 mIU/mL | Standard Deviation 4.11 |
| Androxal 12.5 mg | Change in Leuteinizing Hormone (LH) | Morning LH at Baseline | 4.82 mIU/mL | Standard Deviation 1.63 |
| Androxal 25 mg | Change in Leuteinizing Hormone (LH) | Morning LH at Week 4 | 11.78 mIU/mL | Standard Deviation 7.39 |
| Androxal 25 mg | Change in Leuteinizing Hormone (LH) | Morning LH at Baseline | 4.98 mIU/mL | Standard Deviation 3.45 |
| Androxal 25 mg | Change in Leuteinizing Hormone (LH) | Morning LH at Week 2 | 9.64 mIU/mL | Standard Deviation 5.04 |
| Androxal 25 mg | Change in Leuteinizing Hormone (LH) | Morning LH Change from Baseline at Week 2 | 4.66 mIU/mL | Standard Deviation 3.56 |
| Androxal 25 mg | Change in Leuteinizing Hormone (LH) | Morning LH Change from Baseline at Week 4 | 6.79 mIU/mL | Standard Deviation 5.54 |
| Androxal 25 mg | Change in Leuteinizing Hormone (LH) | Morning LH at Week 6 | 14.5 mIU/mL | Standard Deviation 10.5 |
| Androxal 25 mg | Change in Leuteinizing Hormone (LH) | Morning LH Change from Baseline at Week 6 | 9.51 mIU/mL | Standard Deviation 8.15 |
| AndroGel | Change in Leuteinizing Hormone (LH) | Morning LH Change from Baseline at Week 2 | -1.57 mIU/mL | Standard Deviation 2.2 |
| AndroGel | Change in Leuteinizing Hormone (LH) | Morning LH Change from Baseline at Week 6 | -1.41 mIU/mL | Standard Deviation 2.01 |
| AndroGel | Change in Leuteinizing Hormone (LH) | Morning LH at Week 6 | 2.2 mIU/mL | Standard Deviation 2.8 |
| AndroGel | Change in Leuteinizing Hormone (LH) | Morning LH at Week 2 | 2.00 mIU/mL | Standard Deviation 2.12 |
| AndroGel | Change in Leuteinizing Hormone (LH) | Morning LH at Baseline | 3.57 mIU/mL | Standard Deviation 2.23 |
| AndroGel | Change in Leuteinizing Hormone (LH) | Morning LH Change from Baseline at Week 4 | -1.69 mIU/mL | Standard Deviation 1.58 |
| AndroGel | Change in Leuteinizing Hormone (LH) | Morning LH at Week 4 | 1.88 mIU/mL | Standard Deviation 2.68 |
Comparison: ANOVA results - change from baseline in morning LH at Week 2. Modeling change from baseline by treatment group.p-value: <0.001ANOVA
Comparison: ANOVA results - change from baseline in morning LH at Week 4. Modeling change from baseline by treatment group.p-value: <0.001ANOVA
Comparison: ANOVA results - change from baseline in morning LH at Week 6. Modeling change from baseline by treatment group.p-value: <0.001ANOVA
Other Pre-specified
Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24.
The area under the curve for plasma concentration over time from zero to 24 hours (AUC0-24).
Time frame: Week 6
Population: PK population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Androxal 6.25 mg | Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24. | 21.200 ng*h/mL | Standard Deviation 14.399 |
| Androxal 12.5 mg | Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24. | 34.012 ng*h/mL | Standard Deviation 21.419 |
| Androxal 25 mg | Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24. | 150.51 ng*h/mL | Standard Deviation 132.32 |
Other Pre-specified
Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.
The Cmax for plasma concentration.
Time frame: Week 6
Population: PK population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Androxal 6.25 mg | Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax. | 1.8154 ng/mL | Standard Deviation 0.8358 |
| Androxal 12.5 mg | Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax. | 3.3899 ng/mL | Standard Deviation 2.0239 |
| Androxal 25 mg | Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax. | 16.2993 ng/mL | Standard Deviation 12.8952 |
Other Pre-specified
Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax.
The Tmax for plasma concentration.
Time frame: Week 6
Population: PK population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Androxal 6.25 mg | Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax. | 2.33 h | Standard Deviation 0.98 |
| Androxal 12.5 mg | Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax. | 2.42 h | Standard Deviation 1.21 |
| Androxal 25 mg | Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax. | 2.41 h | Standard Deviation 1.48 |
Post Hoc
Morning Testosterone Correlated With Serial Testosterone.
9 AM morning testosterone correlated with Week 6 serial testosterone Cavg, Cmin, and Cmax. If a subject did not have a Week 6 serial testosterone Cavg, Cmin, or Cmax then they were not included for that particular correlation calculation.
Time frame: Week 6
Population: All Androxal subjects with Week 6 serial testosterone measurements.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Androxal 6.25 mg | Morning Testosterone Correlated With Serial Testosterone. | 35 Number of Subjects |
Comparison: Pearson correlation between 9 am morning testosterone and serial testosterone Cavg at Week 6.p-value: <0.0001t-test, 2 sided
Comparison: Pearson correlation between 9 am morning testosterone and serial testosterone Cmin at Week 6.p-value: <0.0001t-test, 2 sided
Comparison: Pearson correlation between 9 am morning testosterone and serial testosterone Cmax at Week 6.p-value: <0.0001t-test, 2 sided