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Follistatin 315

Activin-Binding Protein, FSH-Suppressing Protein, FST-315, FS-315

Quick Stats
Studies 14
Trials 93
Completed PHASE1 INTERVENTIONAL NCT00100893

IH636 Grape Seed Extract in Preventing Breast Cancer in Postmenopausal Women at Risk of Developing Breast Cancer

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of IH636 grape seed extract may prevent breast cancer. PURPOSE: This phase I trial is studying the side effects and best dose of IH636 grape seed extract in preventing breast cancer in postmenopausal women at risk of developing breast cancer.

Detailed Description

OBJECTIVES: * Determine the efficacy of IH636 grape seed proanthocyanidin extract, in terms of suppression of estrogen biosynthesis, in healthy post-menopausal women at high risk of developing breast cancer. * Determine the safety and tolerability of this dietary supplement, in terms of symptoms and changes in markers of bone and lipid metabolism and in markers of nonspecific adrenal suppression, in these participants. * Determine, preliminarily, an optimum biologic dose of this dietary supplement, as defined by suppression of serum estradiol, in these participants. * Determine a minimum duration of use of this dietary supplement to achieve aromatase inhibition in these participants. OUTLINE: This is a pilot, dose-finding, placebo-controlled study. Participants receive oral placebo once or twice daily on days -14 to 0. Participants then receive oral IH636 grape seed proanthocyanidin extract once or twice daily on days 1-85. Treatment continues in the absence of toxicity. Cohorts of 6 participants receive one of four dose levels of IH636 grape seed proanthocyanidin extract up to an established safe dose. PROJECTED ACCRUAL: A total of 24 participants will be accrued for this study within 12 months.

Interventions

Name: IH636 grape seed proanthocyanidin extract
Type: DIETARY_SUPPLEMENT
Description: Dose escalation as follows: 50 mg/day, 300 mg/day, 1000 mg/day, 2000 mg/day, 2800 mg/day, 4000 mg/day, 4800 mg/day and 6000 mg/day in separate patient groups for each dosage

Primary Outcomes

Measure: Estrogen suppression as measured by serum estradiol, estrone, estrone sulfate, and sex hormone binding globulin
TimeFrame: at 1, 2, 4, 8, and 12 weeks
Description:

Trial Information

NCT ID

NCT00100893

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

City of Hope Medical Center

Last Updated

December 15, 2025

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