Acquired Hypogonadotropic HypogonadismPhase 2NCT02651688

A Multi-Center Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Body Composition and Metabolic Parameters With Diet and Exercise in Conjunction With Treatment With 12.5 mg or 25 mg Enclomiphene

A Phase 2 study testing Enclomiphene in people with Acquired Hypogonadotropic Hypogonadism and Obesity, run by Repros Therapeutics Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to compare the effects of 12 months of treatment with enclomiphene 12.5 mg, 25 mg, or placebo capsules on body composition and metabolic parameters in overweight men with acquired hypogonadotropic hypogonadism [confirmed morning testosterone (T) ≤300 ng/dL] following a 6 month diet and 15… Read more about this study

Who is it for?: Ages 18 to 60 years, men only
Conditions the study is for: Acquired Hypogonadotropic Hypogonadism, Obesity
What is being tested?: Enclomiphene
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 5 sitesUnited States
Study dates: 11 Jan 2016to 2 May 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
Men only
No healthy volunteers
Adult

Who may be able to join

Overweight (Body Mass Index (BMI) 30 to 42 (kg/m^2) inclusive) males age 18 to 60 inclusive.
Waist circumference ≥ 40 inches (101.6 cm).
Previously or concurrently diagnosed as having secondary hypogonadism.
Must have 2 morning testosterone assessments at Visit 1, collected before 10 AM, 2-4 days apart, and both of which must be ≤ 300 (ng/dL).
Luteinizing hormone (LH) >1.4 and < 9.4 milli International units per milliliter (mIU/mL) (at Visit 1 only).
Glycated hemoglobin A1c (HbA1c) ≤7.5.

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Stable weight for last 3 months (+/- 10 pounds).
Participant lives or works within 10 miles of the gym that will be used for the study.
Must be fit enough to participate in the fitness program.
Ability to complete the study in compliance with the protocol requirements.
Ability to understand and provide written informed consent.

Who cannot join

Any use of testosterone products (injectable, pelleted, transdermal or sublingual) in the 6 months prior to the study or any prior use of testosterone products for 12 months or longer at any time.
Use of testosterone, Clomid, 5α-reductase inhibitors, human chorionic gonadotropin (hCG), androgen, estrogen, anabolic steroid, dehydroepiandrosterone (DHEA), or herbal hormone products during the study.
Use of Clomid in the past year.
Known hypersensitivity to Clomid.
Allergy to soy, peanuts or latex.
Chronic use of glucocorticoids (chronic use of inhaled or topical glucocorticoids is acceptable).

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History of drug abuse or chronic narcotic use including methadone.
A recent history of alcoholism or illegal substance or steroid abuse (<2 years) or presence of moderate alcohol use (>21 drinks per week).
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.
A hematocrit >54%.
Presence or known history of hyperprolactinemia with or without a tumor (prolactin >20 ng/mL).
Current or history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a prostate specific antigen (PSA)>3.6.
Current or history of breast cancer.
Uncontrolled hypertension based on the Investigator's assessment at screening.
History of bulimia nervosa or binge eating.
Participant has (had) a lap band or undergone gastric bypass surgery.
Participant has celiac disease or gluten intolerance.
Participant has Type I diabetes.
Participant has 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.
Enrolled and randomized (if applicable) in a previous enclomiphene study.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Study site
Albany, New York, 12208
Study site
Garden City, New York, 11530
Study site
Norfolk, Virginia, 23507
Study site
Providence, Rhode Island, 02903
Study site
Riverton, Utah, 84065

Other trials in United States

About this study

Official title: A Randomized, Double Blind, Placebo-Controlled, Multi-Center Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Body Composition and Metabolic Parameters With Diet and Exercise in Conjunction With Treatment With 12.5 mg or 25 mg Enclomiphene

Read the detailed description

To compare the effects of 12 months of treatment with enclomiphene 12.5 mg, 25 mg, or placebo capsules on body composition and metabolic parameters in overweight men with acquired hypogonadotropic hypogonadism (confirmed morning T≤300 ng/dL) following a 6 month diet and 15 month exercise program. Participants must not have been treated with testosterone products in the 6 months prior to the study and must not ever have used testosterone products for a year or longer.

Conditions: Acquired Hypogonadotropic Hypogonadism, Obesity
Being tested: Placebo, Enclomiphene
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months.
EnclomipheneDrug
Enclomiphene capsule daily in the morning with approximately 8 ounces of water for up to 12 months.

Study groups in NCT02651688
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 0) to Week 48
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.
Measured: Baseline (Day 0) to Week 48
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.
Measured: Baseline (Day 0) to Week 48
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.
Measured: Baseline (Day 0) to Week 48
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.
Measured: Baseline (Day 0) to Week 48
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.
Measured: Baseline (Day 0) to Week 48
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.
Measured: Baseline (Day 0) to Week 48
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.
Measured: Baseline (Day 0) to Week 48
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.
Measured: Baseline (Day 0) to Week 48
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.
Measured: Baseline (Day 0) to Week 48
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.
Measured: Baseline (Day 0) to Week 48
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.
Measured: Baseline (Day 0) to Week 48
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.
Measured: Baseline (Day 0) to Week 48
Change From Baseline in Waist Circumference at Week 48
A negative change from Baseline indicates improvement.
Measured: Baseline (Day 0) to Week 48
Change From Baseline in Weight at Week 48
A negative change from Baseline indicates improvement.
Measured: Baseline (Day 0) to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jan 20162 May 2017

First posted11 Jan 2016 (estimated)
Study start11 Jan 2016
Primary completion2 May 2017
Study completion2 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acquired Hypogonadotropic HypogonadismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02651688
Sponsor's protocol ID: ZA-205
Status last verified: Jun 2019
First submitted: 7 Jan 2016
Last updated: 27 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders

All Acquired Hypogonadotropic Hypogonadism trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, Placebo-Controlled, Multi-Center Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Body Composition and Metabolic Parameters With Diet and Exercise in Conjunction With Treatment With 12.5 mg or 25 mg Enclomiphene
ClinicalTrials.gov ID: NCT02651688
Acronym / sponsor ID: ZA-205
Conditions: Acquired Hypogonadotropic Hypogonadism, Obesity
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Repros Therapeutics Inc.Industry (pharma, biotech, devices)
Study start: 11 Jan 2016 (actual)
Primary completion: 2 May 2017 (actual)
Study completion: 2 May 2017 (actual)
First posted: 11 Jan 2016 (estimated)
Results: Posted 14 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Enclomiphene 12.5 mg	Experimental	Drug: EnclomipheneEnclomiphene 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.
Enclomiphene 25 mg	Experimental	Drug: EnclomipheneEnclomiphene 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.
Placebo	Placebo comparator	Drug: PlaceboOne 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.

Who may qualify

Ages: 18 to 60 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Overweight (Body Mass Index (BMI) 30 to 42 (kg/m^2) inclusive) males age 18 to 60 inclusive.
Waist circumference ≥ 40 inches (101.6 cm).
Previously or concurrently diagnosed as having secondary hypogonadism.
Must have 2 morning testosterone assessments at Visit 1, collected before 10 AM, 2-4 days apart, and both of which must be ≤ 300 (ng/dL).
Luteinizing hormone (LH) >1.4 and < 9.4 milli International units per milliliter (mIU/mL) (at Visit 1 only).

Key exclusion criteria (20 listed)

Any use of testosterone products (injectable, pelleted, transdermal or sublingual) in the 6 months prior to the study or any prior use of testosterone products for 12 months or longer at any time.
Use of testosterone, Clomid, 5α-reductase inhibitors, human chorionic gonadotropin (hCG), androgen, estrogen, anabolic steroid, dehydroepiandrosterone (DHEA), or herbal hormone products during the study.
Use of Clomid in the past year.
Known hypersensitivity to Clomid.
Allergy to soy, peanuts or latex.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboOne matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months.	Drug	Placebo
EnclomipheneEnclomiphene capsule daily in the morning with approximately 8 ounces of water for up to 12 months.	Drug	Enclomiphene 12.5 mg, Enclomiphene 25 mg

Primary outcome

Change From Baseline in Lean Body Mass (LBM) at Week 48
Time frame: Baseline (Day 0) to Week 48
LBM was assessed using dual-energy X-ray absorptiometry (DXA). A positive change from Baseline indicates improvement.
Change From Baseline in Body Strength (Chest Press Weight) at Week 48
Time frame: Baseline (Day 0) to 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.
Change From Baseline in Body Strength (Leg Press Weight) at Week 48
Time frame: Baseline (Day 0) to 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.
Change From Baseline in Blood Luteinizing Hormone (LH) Level at Week 48
Time frame: Baseline (Day 0) to 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.
Change From Baseline in Blood Testosterone (T) Level at Week 48
Time frame: Baseline (Day 0) to 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.
Change From Baseline in Blood Dihydrotestosterone (DHT) Level at Week 48
Time frame: Baseline (Day 0) to 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.
Change From Baseline in Blood Estradiol (E2) Level at Week 48
Time frame: Baseline (Day 0) to 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.
Change From Baseline in Ratio of Testosterone: Estradiol (T:E2) at Week 48
Time frame: Baseline (Day 0) to 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.
Change From Baseline in Ratio of Dihydrotestosterone: Testosterone (DHT:T) at Week 48
Time frame: Baseline (Day 0) to 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.
Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 48
Time frame: Baseline (Day 0) to 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.
Change From Baseline in Blood Glucose Level at Week 48
Time frame: Baseline (Day 0) to 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.
Change From Baseline in Blood C-reactive Protein (CRP) Level at Week 48
Time frame: Baseline (Day 0) to 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.
Change From Baseline in Blood Interleukin-6 (IL-6) Level at Week 48
Time frame: Baseline (Day 0) to 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.
Change From Baseline in Blood Tumor Necrosis Factor Alpha (TNF-α) Level at Week 48
Time frame: Baseline (Day 0) to 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.
Change From Baseline in Blood Leptin Level at Week 48
Time frame: Baseline (Day 0) to 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.
Change From Baseline in Homeostatic Model of Assessment - Insulin Resistance (HOMA-IR) at Week 48
Time frame: Baseline (Day 0) to 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.
Change From Baseline in Blood Quantose-Insulin Resistance (IR) Score at Week 48
Time frame: Baseline (Day 0) to 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.
Change From Baseline in Body Mass Index (BMI) at Week 48
Time frame: Baseline (Day 0) to Week 48
BMI is calculated as weight (kg)/height(cm^2). A negative change from Baseline indicates improvement.
Change From Baseline in Waist Circumference at Week 48
Time frame: Baseline (Day 0) to Week 48
A negative change from Baseline indicates improvement.
Change From Baseline in Weight at Week 48
Time frame: Baseline (Day 0) to Week 48
A negative change from Baseline indicates improvement.

Results and safety

Results posted to the registry on 14 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enclomiphene 12.5 mg	18	16
Enclomiphene 25 mg	17	12
Placebo	15	12

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

Time frame: Baseline (Day 0) to Week 48. Mean (Standard Deviation). Unit: kg

Measure	Enclomiphene 12.5 mg n = 18	Enclomiphene 25 mg n = 17	Placebo n = 15
Baseline	65.23 (7.08)	65.60 (7.88)	68.12 (7.43)
Change from Baseline to week 48	3.14 (4.03)	2.40 (3.54)	1.05 (4.10)

Enclomiphene 12.5 mg vs Placebo: p = 0.7103, Wilcoxon rank-sum test
Enclomiphene 25 mg vs Placebo: p = 0.4529, Wilcoxon rank-sum test

Population analysed: 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.

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

Time frame: Baseline (Day 0) to Week 48. Mean (Standard Deviation). Unit: pounds (lbs)

Measure	Enclomiphene 12.5 mg n = 18	Enclomiphene 25 mg n = 17	Placebo n = 15
Baseline	169.00 (56.46)	180.93 (95.43)	151.50 (63.68)
Change from Baseline to Week 48	75.00 (28.80)	76.90 (51.55)	87.27 (50.61)

Enclomiphene 12.5 mg vs Placebo: p = 0.9302, Wilcoxon rank-sum test
Enclomiphene 25 mg vs Placebo: p = 0.7509, Wilcoxon rank-sum test

Population analysed: 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.

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

Time frame: Baseline (Day 0) to Week 48. Mean (Standard Deviation). Unit: pounds (lbs)

Measure	Enclomiphene 12.5 mg n = 18	Enclomiphene 25 mg n = 17	Placebo n = 15
Baseline	466.06 (291.7)	464.20 (288.2)	580.86 (264.2)
Change from Baseline to Week 48	406.92 (222.2)	323.80 (200.3)	351.50 (216.2)

Enclomiphene 12.5 mg vs Placebo: p = 0.5095, Wilcoxon rank-sum test
Enclomiphene 25 mg vs Placebo: p = 0.6230, Wilcoxon rank-sum test

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

Time frame: Baseline (Day 0) to Week 48. Mean (Standard Deviation). Unit: mIU/mL

Measure	Enclomiphene 12.5 mg n = 18	Enclomiphene 25 mg n = 17	Placebo n = 15
Baseline	3.93 (1.82)	3.41 (0.93)	3.51 (1.31)
Change from Baseline to Week 48	2.40 (3.39)	3.01 (4.70)	0.83 (1.25)

Enclomiphene 12.5 mg vs Placebo: p = 0.2960, Wilcoxon rank-sum test
Enclomiphene 25 mg vs Placebo: p = 0.2723, Wilcoxon rank-sum test

Adverse events

Time frame: From the first dose of the study drug through 30 days of the treatment end date (approximately 13 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enclomiphene 12.5 mg	2 of 18 (11.1%)	13 of 18 (72.2%)	0 of 18
Enclomiphene 25 mg	0 of 17 (0%)	7 of 17 (41.2%)	0 of 17
Placebo	0 of 15 (0%)	13 of 15 (86.7%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acquired Hypogonadotropic Hypogonadism

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anna Chan study director

Allergan

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enclomiphene in people with Acquired Hypogonadotropic Hypogonadism and Obesity, run by Repros Therapeutics Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Lean Body Mass (LBM) at Week 48 (time frame: Baseline (Day 0) to Week 48). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02651688.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019; AzTrials last refreshed its copy on 26 Oct 2026.

Trial summary

Key requirements

Who may be able to join

Who cannot join

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (11 listed)

Key exclusion criteria (20 listed)

Interventions

Primary outcome

Results and safety

Participant flow

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

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

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

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

Adverse events

Research links

Related trials for Acquired Hypogonadotropic Hypogonadism

Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford

Referral and contact

Questions about this trial

Participant flow

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

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

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

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

Adverse events