CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
S-adenosyl-L-methionine disulfate p-toluene-sulfonate +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01140646
NCT01140646Phase 2Completed
CompareCT.gov

Phase II Evaluation of S-Adenosyl-L-Methionine (SAMe) for the Treatment of Hot Flashes

Mayo Clinic·interventional·Posted Jun 9, 2010·Updated Jan 31, 2019

In Brief

A Phase 2 clinical trial evaluating S-adenosyl-L-methionine disulfate p-toluene-sulfonate, questionnaire administration, and 1 other intervention for Healthy, no Evidence of Disease and Hot Flashes. Completed, enrolled 45 participants across 1 site.

Detailed Summary

RATIONALE: S-adenosyl-L-methionine may help relieve hot flashes in women based upon its ability to potentially modulate serotonin. PURPOSE: This phase II trial is studying the side effects and how well s-adenosyl-L-methionine works in treating hot flashes in women with a history of breast cancer or those who do not wish to take estrogen due to a perceived increased risk of breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy, no Evidence of Disease, Hot Flashes
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 9, 2010
Enrollment StartOct 1, 2010
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 16.1 years ago

Interventions

S-adenosyl-L-methionine disulfate p-toluene-sulfonatedrug

Given orally

questionnaire administrationother

Ancillary studies

quality-of-life assessmentprocedure

Ancillary studies