Last reviewed · How we verify
NCT03508648
Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Stress Urinary Incontinence
Phase 2 trial testing GTx-024 in Stress Urinary Incontinence. Withdrawn.
21 September 2018
Quick facts
| Lead sponsor | GTx |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Start date | 28 May 2018 |
| Primary completion | 21 September 2018 |
| Estimated completion | 21 September 2018 |
| Sites | 46 locations across United States |
Drugs / interventions tested
- GTx-024 — full drug profile →
- Matching Placebo — full drug profile →
Conditions studied
- Stress Urinary Incontinence — all drugs for Stress Urinary Incontinence →
Sponsor
GTx — full company profile →
Who can join
Adults 18 to 80, female only, with Stress Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study will enroll only from the first 225 subjects who were randomly assigned to treatment in G201002 (irrespective of the treatment allocation, i.e., GTx-024 or placebo) and who have completed the 12-week treatment period and 16-week durability period to assess the long-term durability of response to GTx-024 on SUI symptoms. The extension study will follow subjects for an additional 20 weeks to help better assess the durability of response in these subjects and will provide additional efficacy and safety data for the subjects. Subjects will not be provided with any study treatments and will be off-drug during this extension study.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Selective androgen receptor modulators: the future of androgen therapy?
Christiansen AR, Lipshultz LI, Hotaling JM, Pastuszak AW. · · 2020 · cited 74× · PMID 32257854 · DOI 10.21037/tau.2019.11.02 -
Pathogenesis, Intervention, and Current Status of Drug Development for Sarcopenia: A Review.
Jang JY, Kim D, Kim ND. · · 2023 · cited 36× · PMID 37371730 · DOI 10.3390/biomedicines11061635
Verify or expand the search:
- PubMed search for NCT03508648
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of GTx-024
Trials testing the same drug.
- NCT03566290 — Study to Assess Long-Term Safety/Tolerability of Enobosarm (GTx 024) in Stress Urinary Incontinence · Phase 2 · withdrawn
Other recruiting trials for Stress Urinary Incontinence
Currently open trials in the same condition.
- NCT06706362 — Assessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid (Bulkamid Study) · Phase 4 · recruiting
- NCT06924450 — Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery · NA · recruiting
- NCT06840093 — Outcomes of Limited Postoperative Restrictions Following Sling Placement: A Randomized Controlled Trial · NA · recruiting
- NCT06111209 — The Anabolic Effect of Testosterone on Pelvic Floor Muscles · Phase 2 · recruiting
- NCT06731985 — The Follow-up After Shorter Tapes Study. Effectiveness and Safety of Shorter Trans-obturator Tapes. · recruiting
Other GTx trials
Trials by the same sponsor.
- NCT03566290 — Study to Assess Long-Term Safety/Tolerability of Enobosarm (GTx 024) in Stress Urinary Incontinence · Phase 2 · withdrawn
- NCT03241342 — Study to Assess Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence · Phase 2 · completed
- NCT01615120 — Study of the Effect of GTx-758 on Serum PSA and Testosterone in Men With Prostate Cancer · Phase 2 · completed
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 NCT03508648 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GTx
- Last refreshed: 14 September 2023
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/NCT03508648.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing