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Trial · Interventional

WithdrawnPhase 2/3Registry data

Androxal in Male Infertility

Overview

Status
Withdrawn
Phase
Phase 2/3
Enrollment
0 participants (actual)
Sponsor
Baylor College of Medicine · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
22 Sept 2014
Primary completion
2 Aug 2016
Completion
2 Aug 2016
First posted
11 Jun 2014 (estimated)
Last update posted
11 Jul 2019
Conditions
Infertility

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2014201520162017
  1. Ph 2/3

    Androxal in Male Infertility

    NCT02160704

    22 Sept 2014 to 2 Aug 2016

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Enclomiphene citrateDrug
  • PlaceboOther

Arms2

  • Experimental

    Arm 1(IP)

    Enclomiphene citrate capsules 25 mg 1x daily for 16 weeks

  • Placebo comparator

    Arm 2 (Placebo)

    Placebo capsule 1x daily for 16 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Doubling of total motile sperm count

    Time frame · 16 weeks

Secondary outcomes(3)
  1. Morning hormone levels

    Time frame · 16 weeks

    Registry description

    Assess changes in values from baseline of total morning testosterone, estrogen and dihydrotestosterone levels after 16 weeks of treatment with placebo or 25 mg Androxal

  2. Changes in questionnaire responses

    Time frame · 16 weeks

    Registry description

    Assess change from baseline to endpoint in Androgen Deficiency Aging Male (ADAM), International Prostate Symptom Score (I-PSS), Sexual health inventory in Male (SHIM) and psychosexual daily questionnaire (PDQ)

  3. BMI

    Time frame · 16 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 35 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Subjects with cystic fibrosis (mutation of the CFTR gene) * History of liver disease (including malignancy) or a confirmed AST or ALT \>3 times the upper limit of normal * History of myocardial infarction, unstable angina, symptomatic heart failure, ventricular dysrhythmia or known history of QTc interval prolongation * History of cerebrovascular disease * History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism) * History of erythrocytosis or polycythemia (HCt \> 54)

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