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NCT06161792: VMS
Evaluate RCN3028 in Treatment of Drug-Induced VMS in Breast Cancer
Phase 2 trial testing 0.8 mg RCN3028 in Hot Flashes in 10 participants. Terminated before completion.
14 March 2022
Quick facts
| Lead sponsor | Yung Shin Pharm. Ind. Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 7 November 2019 |
| Primary completion | 14 March 2022 |
| Estimated completion | 20 April 2022 |
| Sites | 4 locations across Taiwan |
Drugs / interventions tested
- 0.8 mg RCN3028 — full drug profile →
- Placebo
Conditions studied
- Hot Flashes — all drugs for Hot Flashes →
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Yung Shin Pharm. Ind. Co., Ltd. — full company profile →
Who can join
Adults 18 to 80, female only, with Hot Flashes or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Due to the fact that majority of breast cancers are estrogen-receptor and/or progesterone receptor positive, tamoxifen and aromatase inhibitors (AIs) are among the mainstay therapies to treat breast cancer. Prior clinical studies of tamoxifen suggested that up to 80 % of patients experienced hot flashes during therapy with tamoxifen, and 30 % defined their symptoms as severe. Despite the high efficacy of tamoxifen, the harmful side effects have been identified in previous studies as a significant reason for not persisting with the treatment in 16 - 30 % of breast cancer patients. The primary purpose of this study is to determine if RCN3028 is effective and safe in the treatment of moderate to severe vasomotor symptoms associated. In accordance with the latest FDA guidance study participants will have a minimum of 7 moderate to sever hot flashes per day, or 50 per week at baseline.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06161792
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hot Flashes
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
- NCT07455812 — A Study in Germany to Learn About the Value of Fezolinetant in Treating Hot Flashes and Night Sweats in Women During Men · active not recruiting
- NCT06716554 — Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, P · NA · recruiting
- NCT06440967 — A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy · Phase 3 · active not recruiting
Other Yung Shin Pharm. Ind. Co., Ltd. trials
Trials by the same sponsor.
- NCT06600282 — Bioequivalence of Two Formulations of Parecoxib in Healthy Volunteers Under Fasting Conditions · Phase 4 · not yet recruiting
- NCT05654090 — Evaluate Bioequivalence of Burotam (1/1 g/Vial) · Phase 4 · unknown
- NCT05496725 — Evaluate Bioequivalence of Micafungin (50mg/Vial) · Phase 4 · completed
- NCT04585412 — Evaluate Bioequivalence of Palonosetron (0.25mg/5mL) · Phase 4 · completed
- NCT04552353 — Evaluate Bioequivalence of Voriconazole(200mg/Vial) . · Phase 4 · 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 NCT06161792 (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 Yung Shin Pharm. Ind. Co., Ltd.
- Last refreshed: 8 December 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/NCT06161792.
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