A Multi-Center Study in Men With Acquired Hypogonadotropi... | NCT02651688

Label	Type	Description	Intervention Names
Enclomiphene 12.5 mg	Experimental	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participant followed a commercial diet plan and exercised with a personal trainer at least 3 times a week.	Drug: Enclomiphene
Enclomiphene 25 mg	Experimental	Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participant followed a commercial diet plan and exercised with a personal trainer at least 3 times a week.	Drug: Enclomiphene
Placebo	Placebo Comparator	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participant followed a commercial diet plan and exercised with a personal trainer at least 3 times a week.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months.	Placebo

Measure	Description	Time Frame
Change From Baseline in Lean Body Mass (LBM) at Week 48	LBM was assessed using dual-energy X-ray absorptiometry (DXA). A positive change from Baseline indicates improvement.	Baseline (Day 0) to Week 48
Change From Baseline in Body Strength (Chest Press Weight) at Week 48	Body strength was assessed from maximum chest and leg press weight achieved, using an inclined plane leg press and vertical chest press. A positive change from Baseline indicates improvement.	Baseline (Day 0) to Week 48
Change From Baseline in Body Strength (Leg Press Weight) at Week 48	Body strength was assessed from maximum chest and leg press weight achieved, using an inclined plane leg press and vertical chest press. A positive change from Baseline indicates improvement.	Baseline (Day 0) to Week 48
Change From Baseline in Blood Luteinizing Hormone (LH) Level at Week 48	A blood sample was collected at Baseline and Week 48 for the assessment of the hormone parameter LH measured in milli-International Units per milliliter (mIU/mL). A positive change from Baseline indicates improvement.	Baseline (Day 0) to Week 48
Change From Baseline in Blood Testosterone (T) Level at Week 48	A blood sample was collected at Baseline and Week 48 for the assessment of the hormone parameter T. A positive change from Baseline indicates improvement.	Baseline (Day 0) to Week 48
Change From Baseline in Blood Dihydrotestosterone (DHT) Level at Week 48	A blood sample was collected at Baseline and Week 48 for the assessment of the hormone parameter DHT. A positive change from Baseline indicates improvement.

Name	Affiliation	Role
Anna Chan	Allergan	Study Director

ID	Title	Description
FG000	Enclomiphene 12.5 mg	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
FG001	Enclomiphene 25 mg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Jul 29, 2016	May 23, 2019

ID	Title	Description
BG000	Enclomiphene 12.5 mg	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
BG001	Enclomiphene 25 mg	Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
BG002	Placebo	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00018 BG00117 BG00215 BG00350

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Lean Body Mass (LBM) at Week 48

LBM was assessed using dual-energy X-ray absorptiometry (DXA). A positive change from Baseline indicates improvement.

Intent to treat (ITT) population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.

Posted

Mean

Standard Deviation

Baseline (Day 0) to Week 48

ID	Title	Description
OG000	Enclomiphene 12.5 mg	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG001	Enclomiphene 25 mg	Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG002	Placebo	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.

Units	Counts
Participants	OG00018 OG00117 OG00215

Title

Denominators

Categories

Baseline

- ParticipantsOG00018
- ParticipantsOG00117
- ParticipantsOG00215

Title	Measurements

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Wilcoxon rank-sum test		0.7103														Superiority
OG001 OG002		Wilcoxon rank-sum test		0.4529

Primary

Change From Baseline in Body Strength (Chest Press Weight) at Week 48

Body strength was assessed from maximum chest and leg press weight achieved, using an inclined plane leg press and vertical chest press. A positive change from Baseline indicates improvement.

ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.

Posted

Mean

Standard Deviation

pounds (lbs)

Baseline (Day 0) to Week 48

ID	Title	Description
OG000	Enclomiphene 12.5 mg	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG001	Enclomiphene 25 mg	Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG002	Placebo	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.

Primary

Change From Baseline in Body Strength (Leg Press Weight) at Week 48

Body strength was assessed from maximum chest and leg press weight achieved, using an inclined plane leg press and vertical chest press. A positive change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

pounds (lbs)

Baseline (Day 0) to Week 48

ID	Title	Description
OG000	Enclomiphene 12.5 mg	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG001	Enclomiphene 25 mg	Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG002	Placebo	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.

Primary

Change From Baseline in Blood Luteinizing Hormone (LH) Level at Week 48

A blood sample was collected at Baseline and Week 48 for the assessment of the hormone parameter LH measured in milli-International Units per milliliter (mIU/mL). A positive change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

mIU/mL

Baseline (Day 0) to Week 48

ID	Title	Description
OG000	Enclomiphene 12.5 mg	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG001	Enclomiphene 25 mg	Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG002	Placebo	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.

Primary

Change From Baseline in Blood Testosterone (T) Level at Week 48

A blood sample was collected at Baseline and Week 48 for the assessment of the hormone parameter T. A positive change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

ng/dL

Baseline (Day 0) to Week 48

ID	Title	Description
OG000	Enclomiphene 12.5 mg	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG001	Enclomiphene 25 mg	Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG002	Placebo	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.

Primary

Change From Baseline in Blood Dihydrotestosterone (DHT) Level at Week 48

A blood sample was collected at Baseline and Week 48 for the assessment of the hormone parameter DHT. A positive change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

nanogram per deciliter (ng/dL)

Baseline (Day 0) to Week 48

ID	Title	Description
OG000	Enclomiphene 12.5 mg	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG001	Enclomiphene 25 mg	Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG002	Placebo	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.

Primary

Change From Baseline in Blood Estradiol (E2) Level at Week 48

A blood sample was collected at Baseline and Week 48 for the assessment of the hormone parameter E2. A positive change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

pg/mL

Baseline (Day 0) to Week 48

ID	Title	Description
OG000	Enclomiphene 12.5 mg	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG001	Enclomiphene 25 mg	Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG002	Placebo	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.

Primary

Change From Baseline in Ratio of Testosterone: Estradiol (T:E2) at Week 48

The T:E2 ratio was calculated as the value of T/value of E2 using the same units. A positive change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

ratio

Baseline (Day 0) to Week 48

ID	Title	Description
OG000	Enclomiphene 12.5 mg	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG001	Enclomiphene 25 mg	Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG002	Placebo	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.

Primary

Change From Baseline in Ratio of Dihydrotestosterone: Testosterone (DHT:T) at Week 48

The DHT:T ratio was calculated as the value of DHT/value of T using the same units. A negative change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

ratio

Baseline (Day 0) to Week 48

ID	Title	Description
OG000	Enclomiphene 12.5 mg	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG001	Enclomiphene 25 mg	Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG002	Placebo	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.

Primary

Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 48

A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter HbA1c. A negative change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

percentage of HbA1c

Baseline (Day 0) to Week 48

ID	Title	Description
OG000	Enclomiphene 12.5 mg	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG001	Enclomiphene 25 mg	Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG002	Placebo	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.

Primary

Change From Baseline in Blood Glucose Level at Week 48

A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter Glucose. A negative change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

pg/mL

Baseline (Day 0) to Week 48

ID	Title	Description
OG000	Enclomiphene 12.5 mg	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG001	Enclomiphene 25 mg	Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG002	Placebo	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.

Primary

Change From Baseline in Blood C-reactive Protein (CRP) Level at Week 48

A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter CRP. A negative change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

mg/dL

Baseline (Day 0) to Week 48

ID	Title	Description
OG000	Enclomiphene 12.5 mg	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG001	Enclomiphene 25 mg	Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG002	Placebo	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.

Primary

Change From Baseline in Blood Interleukin-6 (IL-6) Level at Week 48

A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter IL-6. A negative change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

pg/mL

Baseline (Day 0) to Week 48

ID	Title	Description
OG000	Enclomiphene 12.5 mg	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG001	Enclomiphene 25 mg	Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG002	Placebo	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.

Primary

Change From Baseline in Blood Tumor Necrosis Factor Alpha (TNF-α) Level at Week 48

A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter TNF-α . A negative change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

pg/mL

Baseline (Day 0) to Week 48

ID	Title	Description
OG000	Enclomiphene 12.5 mg	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG001	Enclomiphene 25 mg	Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG002	Placebo	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.

Primary

Change From Baseline in Blood Leptin Level at Week 48

A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter leptin. A negative change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

ng/mL

Baseline (Day 0) to Week 48

ID	Title	Description
OG000	Enclomiphene 12.5 mg	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG001	Enclomiphene 25 mg	Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG002	Placebo	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.

Primary

Change From Baseline in Homeostatic Model of Assessment - Insulin Resistance (HOMA-IR) at Week 48

The HOMA-IR is the product of the blood Glucose and Insulin levels, divided by a constant. HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/mL) × fasting plasma glucose (mmol/L)/22.5. A negative change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

units on a scale

Baseline (Day 0) to Week 48

ID	Title	Description
OG000	Enclomiphene 12.5 mg	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG001	Enclomiphene 25 mg	Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG002	Placebo	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.

Primary

Change From Baseline in Blood Quantose-Insulin Resistance (IR) Score at Week 48

Quantose-IR is a laboratory-developed test that assesses insulin resistance. Quantose-IR score is based on a linear regression algorithm utilizing the quantitative measures (natural log transformed) of alpha-hydroxybutyrate, oleate, linoleoylglycerophosphocholine and insulin and was designed to estimate the natural log of insulin-induced glucose infusion rate normalized by whole body mass. The algorithm score is converted to the Quantose-IR score within a range of 1-120 by an arithmetic calculation where higher scores denote greater insulin resistance. A negative change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

Quantose-IR score

Baseline (Day 0) to Week 48

ID	Title	Description
OG000	Enclomiphene 12.5 mg	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG001	Enclomiphene 25 mg	Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.

Primary

Change From Baseline in Body Mass Index (BMI) at Week 48

BMI is calculated as weight (kg)/height(cm^2). A negative change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

kg/cm^2

Baseline (Day 0) to Week 48

ID	Title	Description
OG000	Enclomiphene 12.5 mg	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG001	Enclomiphene 25 mg	Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG002	Placebo	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.

Primary

Change From Baseline in Waist Circumference at Week 48

A negative change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

Baseline (Day 0) to Week 48

ID	Title	Description
OG000	Enclomiphene 12.5 mg	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG001	Enclomiphene 25 mg	Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG002	Placebo	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.

Primary

Change From Baseline in Weight at Week 48

A negative change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

Baseline (Day 0) to Week 48

ID	Title	Description
OG000	Enclomiphene 12.5 mg	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG001	Enclomiphene 25 mg	Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.
OG002	Placebo	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ventricular extrasystoles	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected17 at risk EG0021 affected15 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected17 at risk EG0020 affected15 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected17 at risk EG0020 affected15 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected17 at risk EG0021 affected15 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected17 at risk EG0021 affected15 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected17 at risk EG0021 affected15 at risk
Toothache	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected17 at risk EG0021 affected15 at risk
Asthenia	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected17 at risk EG0020 affected15 at risk
Chest discomfort	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected17 at risk EG0021 affected15 at risk
Night sweats	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected17 at risk EG0021 affected15 at risk
Oedema peripheral	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected17 at risk EG0020 affected15 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected18 at risk EG0012 affected17 at risk EG0021 affected15 at risk
Coxsackie viral infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected17 at risk EG0020 affected15 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected17 at risk EG0022 affected15 at risk
Influenza	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0011 affected17 at risk EG0020 affected15 at risk
Viral pharyngitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected17 at risk EG0020 affected15 at risk
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected17 at risk EG0021 affected15 at risk
Food poisoning	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected17 at risk EG0021 affected15 at risk
Nasopharyngitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected17 at risk EG0020 affected15 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected17 at risk EG0020 affected15 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected17 at risk EG0020 affected15 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected17 at risk EG0020 affected15 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected17 at risk EG0021 affected15 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected17 at risk EG0021 affected15 at risk
Electrocardiogram abnormal	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected17 at risk EG0020 affected15 at risk
Haematocrit increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0011 affected17 at risk EG0020 affected15 at risk
Heart rate increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected17 at risk EG0021 affected15 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected17 at risk EG0020 affected15 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected17 at risk EG0021 affected15 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected17 at risk EG0022 affected15 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0011 affected17 at risk EG0020 affected15 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected17 at risk EG0023 affected15 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected17 at risk EG0021 affected15 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected17 at risk EG0020 affected15 at risk
Ligament sprain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected17 at risk EG0020 affected15 at risk
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0011 affected17 at risk EG0020 affected15 at risk
Seizure	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected17 at risk EG0020 affected15 at risk
Anxiety	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected17 at risk EG0020 affected15 at risk
Insomnia	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected17 at risk EG0020 affected15 at risk
Irritability	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected17 at risk EG0020 affected15 at risk
Panic attack	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected17 at risk EG0020 affected15 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected17 at risk EG0020 affected15 at risk
Pharyngeal ulceration	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected17 at risk EG0020 affected15 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected17 at risk EG0020 affected15 at risk
Laceration	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected17 at risk EG0020 affected15 at risk
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected17 at risk EG0020 affected15 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected18 at risk EG0011 affected17 at risk EG0020 affected15 at risk
Vasectomy	Surgical and medical procedures	MedDRA 20.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected17 at risk EG0021 affected15 at risk
Haemorrhoids	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected18 at risk EG0010 affected17 at risk EG0020 affected15 at risk
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected18 at risk EG0010 affected17 at risk EG0021 affected15 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Albany	New York	12208	United States

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D002996	Clomiphene
D013267	Stilbenes
D001597	Benzylidene Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Enclomiphene 12.5 mg	Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.	18	2	18	13	18
EG001	Enclomiphene 25 mg	Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.	17	0	17	7	17
EG002	Placebo	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participants followed a commercial diet plan and exercise with a personal trainer at least 3 times a week.	15	0	15	13	15

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected18 at risk EG0010 affected17 at risk EG0020 affected15 at risk
Ischaemic stroke	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected18 at risk EG0010 affected17 at risk EG0020 affected15 at risk