Clinical trial · Interventional
Pregabalin in Treating Women With Hot Flashes
A Phase III, Randomized, Double-Blind, Placebo-Controlled Evaluation of Pregabalin for Alleviating Hot Flashes
NCT00702949CI-TRIAL-00023322completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Pregabalin may help relieve hot flashes in women with a history of breast cancer or those who have no history and do not wish to take estrogen therapy for fear of increased risk of breast cancer. It is not yet known what dose of pregabalin may be more effective in treating hot flashes. PURPOSE: This is a randomized phase III trial to determine the efficacy of two doses of pregabalin, in comparison to placebo, in the prevention of hot flashes.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Hot Flashes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Other | — | UNRESOLVED |
| pregabalin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Pregabalin75
- description
- Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
- interventionNames
- Drug: pregabalin
- type
- EXPERIMENTAL
- label
- Pregabalin150
- description
- Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
- interventionNames
- Drug: pregabalin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients receive oral placebo twice daily for 6 weeks.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Meeting 1 of the following criteria: * History of breast cancer (currently without malignant disease) * No history of breast cancer, but patient wishes to avoid estrogen due to a perceived increased risk of breast cancer * Bothersome hot flashes (defined by their occurrence ≥ 28 times per week and of sufficient severity to make the patient desire therapeutic intervention) * Presence of hot flashes for ≥ 1 month prior to study entry PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Life expectancy ≥ 6 months * Able to complete questionnaire(s) by themselves or with assistance * Women of childbearing potential not eligible (per the judgment of the attending clinician) * Serum creatinine ≤ 1.5 times upper limit of normal PRIOR CONCURRENT THERAPY: * No prior gabapentin or pregabalin * More than 4 weeks since prior and no concurrent antineoplastic chemotherapy, androgens, estrogens, or progestational agents * Vaginal estrogen is allowed if used for the past month and not planned to be discontinued * Concurrent adjuvant targeted therapy (i.e., lapatinib, trastuzumab \[Herceptin®\]) allowed in patients with no evidence of disease * Concurrent tamoxifen, raloxifene, or aromatase inhibitors on a constant dose for at least 4 weeks allowed provided the medication will not be stopped during the study period * No concurrent or planned use of other agents for hot flashes except for any of the following: * Stable dose of vitamin E is allowed as long as agent was started \> 30 days prior to study initiation and is to be continued throughout the study period * Soy is allowed, if it is planned to be continued at the same dose during the study period * Stable dose of antidepressants is allowed as long as it was started \> 30 days prior to study initiation and is to be continued at a stable dose throughout the study period
References
Publications (1)
- RESULTLoprinzi CL, Qin R, Stella PJ, et al.: Pregabalin for hot flashes in women: NCCTG trial N07C1. [Abstract] J Clin Oncol 27 (Suppl 15): A-9513, 2009.