Androxal in Male Infertility

NCT02160704 | Withdrawn Phase 2

• 1 other identifier: H-33673
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is an exploratory, single center, randomized, parallel, double-blind placebo- and active-controlled trial in adult males ages 18 to 35 years of age who have male infertility of unknown cause. Approximately 50 men will be randomly assigned to one of two treatment groups according to a 1:1 ratio. About half of the men will receive 25mg Androxal and half of the men will receive a placebo (non-active pill) for 16 weeks. This study will last approximately 4 months and involve up to 7 visits. The purpose of this study is to determine the effect the Androxal on sperm production.

Conditions

Infertility

Keywords

Sperm density; Testosterone; Hypogonadism

Outcome Measures

Primary Outcomes (1)

• Doubling of total motile sperm count

  16 weeks

Secondary Outcomes (3)

• Morning hormone levels

  16 weeks

• Changes in questionnaire responses

  16 weeks

• BMI

  16 weeks

Study Arms (2)

Arm 1(IP)

EXPERIMENTAL

Enclomiphene citrate capsules 25 mg 1x daily for 16 weeks

Drug: Enclomiphene citrate

Arm 2 (Placebo)

PLACEBO COMPARATOR

Placebo capsule 1x daily for 16 weeks

Other: Placebo

Interventions

Enclomiphene citrate DRUG

25 mg daily for 16 weeks

Also known as: Androxal

Arm 1(IP)

Placebo OTHER

placebo daily for 16 weeks

Also known as: sugar pill

Arm 2 (Placebo)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men having idiopathic male infertility with sperm concentration \<15million/ml (on 2 baseline semen analyses)
• Serum total testosterone \< 300ng/dL if oligospermia (sperm concentration \<15million/ml)
• Any testosterone if nonobstructive azoospermia (no sperm in the ejaculate)
• Men aged 18-35 living in stable relationship and desiring fertility
• Normal female partner evaluation as reported by the patient
• Ability to complete the study in compliance with the protocol
• Ability to understand and provide written informed consent

You may not qualify if:

• Men desiring operation for fertility (i.e. varicocelectomy) or couples desiring assisted reproductive technologies such as intrauterine insemination IUI, in vitro fertilization IVF and intracytoplasmic sperm injection ICSI) within study completion (5 months)
• Clinically significant medical condition rendering the subjects infertile including tumors of the pituitary, laboratory abnormalities
• Patients having received an investigational drug / clomiphene citrate, antioxidants, multi-vitamin in the past 30 days prior to study
• Previous treatment with androgens, estrogens, DHEA, testosterone or testosterone analogues in injectable, oral, topical or other forms for the treatment of AIHH who have not discontinued for at least 1 month prior to the start of the treatment phase
• Clinically significant abnormal findings on screening examination as determined by the investigator
• Known hypersensitivity to clomiphene citrate
• Current or history of breast cancer
• Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with the study instructions, possibly confound interpretation of the study results, or endanger the participant if he took part in the study
• Have received a diagnosis of irreversible infertility or compromised fertility (cryptorchidism, Kallman Syndrome, vasectomy, or tumors of the pituitary)
• Current or history of prostate cancer or a suspicion of prostate disease
• Presence or history of known hyperprolactinemia (prolactin \> 17ng/dl) with or without a tumor
• Chronic use of medications use such as glucocorticoids (chronic use of inhaled or topical glucocorticoids is acceptable)
• No current drug abuse or chronic narcotic use including methadone
• Subjects with known history of HIV and/or Hepatitis C
• Subjects with end stage renal disease

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Infertility; Hypogonadism

Interventions

Enclomiphene; Sugars

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Clomiphene; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Carbohydrates

Study Officials

• Larry I. Lipshultz, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Study Record Dates

• First Submitted: June 5, 2014
• First Posted: June 11, 2014
• Study Start: September 22, 2014
• Primary Completion: August 2, 2016
• Study Completion: August 2, 2016
• Last Updated: July 11, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)