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NCT05312567
FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor Symptoms
Phase 2 trial testing FP-101 in Vasomotor Symptoms in 105 participants. Completed in 31 July 2023.
5 April 2023
Quick facts
| Lead sponsor | Fervent Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 105 |
| Start date | 24 March 2021 |
| Primary completion | 5 April 2023 |
| Estimated completion | 31 July 2023 |
| Sites | 12 locations across United States |
Drugs / interventions tested
- FP-101 — full drug profile →
Conditions studied
- Vasomotor Symptoms — all drugs for Vasomotor Symptoms →
- Menopause — all drugs for Menopause →
Sponsor
Fervent Pharmaceuticals — full company profile →
Who can join
46 and older, female only, with Vasomotor Symptoms or Menopause. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This Phase II proof of concept study is designed to assess the safety and efficacy of FP-101 (60mg b.i.d.), an extended-release oral tablet product, compared to a matching placebo in the treatment of moderate-to-severe hot flashes in peri- and post-menopausal women over a period of 1-week.
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 NCT05312567
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of FP-101
Trials testing the same drug.
- NCT03285672 — FP-101 for the Treatment of Hot Flashes in Postmenopausal Women · Phase 2 · completed
Other recruiting trials for Vasomotor Symptoms
Currently open trials in the same condition.
- NCT06957691 — Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Pro · Phase 2 · recruiting
- NCT07335224 — Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture · NA · recruiting
- NCT07112651 — Efficacy of CL25216 on Vasomotor Symptoms in Women During Perimenopause · NA · recruiting
- NCT07042516 — Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS). · Phase 2 · recruiting
- NCT06628388 — Nurse-led Primary Healthcare Intervention Model in Women's Health Management in Hong Kong · NA · recruiting
Other Fervent Pharmaceuticals trials
Trials by the same sponsor.
- NCT03285672 — FP-101 for the Treatment of Hot Flashes in Postmenopausal Women · 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 NCT05312567 (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 Fervent Pharmaceuticals
- Last refreshed: 26 October 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/NCT05312567.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing