Last reviewed · How we verify
NCT01880086
Clomiphene Citrate for the Treatment of Opioid-Induced Androgen Deficiency: Randomized Controlled Clinical Trial
Phase 2 trial testing Clomiphene citrate in Hypogonadism in 13 participants. Completed in 1 November 2017.
1 March 2016
Quick facts
| Lead sponsor | Weill Medical College of Cornell University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 1 August 2013 |
| Primary completion | 1 March 2016 |
| Estimated completion | 1 November 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Clomiphene citrate — full drug profile →
- Placebo
Conditions studied
- Hypogonadism — all drugs for Hypogonadism →
- Opioid-Related Disorders — all drugs for Opioid-Related Disorders →
- Male Infertility — all drugs for Male Infertility →
Sponsor
Weill Medical College of Cornell University
Who can join
Adults 18 to 65, male only, with Hypogonadism or Opioid-Related Disorders. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Serum Total Testosterone (Change From Baseline)
Time frame: 3 months post initial visit
Morning venipuncture of serum total testosterone.
Sponsor's own description
The purpose of this randomized controlled clinical trial is to evaluate the effects of clomiphene citrate compared to placebo (substance without active medication) in men who are taking pain medication (opioids) for chronic pain conditions and who have low blood testosterone levels. The condition of men having low testosterone with long-term pain medication (opioid) usage is called opioid-induced androgen deficiency (OPIAD). Low testosterone can be caused by pain medication effects on part of the brain (hypothalamic-pituitary axis) which ultimately result in decreased testosterone production by the testes. Typical symptoms of low testosterone (hypogonadism) may include decreased muscle mass, increased fat, osteoporosis, anemia, erectile dysfunction, delayed ejaculation. In addition, men with low testosterone may experience decreased attention, and decreased libido, fatigue, and depressed mood. Few studies have looked at hormonal changes caused by long-term opioid usage in men. Clomiphene citrate, a selective estrogen receptor modulator (SERM) oral medication which inhibits estrogen effects (feedback) on the brain, has been identified by prior studies to raise testosterone in men with low testosterone (due to reasons other than chronic pain medication). Clomiphene citrate is also known to lead to increased sperm production in men with low testosterone unlike testosterone topical or injection medications. Although clomiphene citrate has been studied in hypogonadal men with beneficial outcomes and minimal side effects, no group has previously studied clomiphene citrate as treatment in patients with OPIAD.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01880086
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Clomiphene citrate
Trials testing the same drug.
- NCT02865681 — Protocol to Minimize Injections and Blood Draws for Women Undergoing in Vitro Fertilization · NA · completed
Other recruiting trials for Hypogonadism
Currently open trials in the same condition.
- NCT06455969 — Adaptions and Resiliency to Multi-Stressor OpeRations · Phase 4 · recruiting
- NCT06280807 — Observation of Environment and Reproductive-Endocrine Effects · recruiting
- NCT04460872 — Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury · Phase 2 · recruiting
- NCT04731376 — Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testo · Phase 1 · active not recruiting
- NCT03887936 — Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism · Phase 4 · active not recruiting
Other Weill Medical College of Cornell University trials
Trials by the same sponsor.
- NCT07485712 — Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 2 · NA · not yet recruiting
- NCT05811338 — Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 1 · NA · not yet recruiting
- NCT06118983 — Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF) · NA · recruiting
- NCT06818734 — Implementation of a Clinical Decision Support Tool for Postpartum Depression · NA · not yet recruiting
- NCT07485725 — Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 3 · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01880086 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Weill Medical College of Cornell University
- Last refreshed: 18 June 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01880086.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing