NCT00997893: RISE

Effects of Estradiol and Soy on Menopausal Symptoms

Completed Phase 2 Results posted Last updated 12 November 2020

What this trial tests

Phase 2 trial testing Soy Phytoestrogen in Menopause in 96 participants. Completed in 1 May 2015.

Timeline

1 December 2009

Primary endpoint
1 May 2015

1 May 2015

Quick facts

Lead sponsor	University of Illinois at Chicago
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	96
Start date	1 December 2009
Primary completion	1 May 2015
Estimated completion	1 May 2015
Sites	1 location across United States

Drugs / interventions tested

• Soy Phytoestrogen
• Estradiol (ESTRADIOL) — full drug profile →
• Medroxyprogesterone Acetate (MPA) — full drug profile →
• Soy Placebo — full drug profile →
• MPA Placebo

Conditions studied

• Menopause — all drugs for Menopause →
• Hot Flashes — all drugs for Hot Flashes →

Sponsor

University of Illinois at Chicago

Who can join

Adults 40 to 65, female only, with Menopause or Hot Flashes. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in STAI-6 Score
  Time frame: Week 0, 10, 12, and 16-18
  STAI-6; State-Trait Anxiety Inventory- Short Form is a measure of anxiety where higher scores indicate higher/elevated anxiety. Minimum value 6 is and maximum value is 24.
• Changes in STAI-6 Scores Before and After Psychosocial Stressor Over Time
  Time frame: Baseline (Week 0) and Treatment (Week 12)
  STAI-6; State-Trait Anxiety Inventory- Short Form is a measure of anxiety where higher scores indicate higher/elevated anxiety. Minimum value 6 is and maximum value is 24.
• Memory for Emotionally Valent Words and Neutral Words
  Time frame: Baseline (Week 0) and Treatment (Week 12)
  Proportion correct out of 18 word pairs (6 positive, 6 negative and 6 neutral) after laboratory-induced stress using Trier Social Stress Test (TSST). Maximum score is 18 and minimum score is 0; higher scores indicate a better score.
• Change in Verbal Memory, Immediate Recall
  Time frame: Baseline and 12 weeks
  Immediate recall on the Logical Memory subset of the Wechsler Memory Scale-Revised, in which higher scores indicate a better recall and outcome. The minimum value is 0 and maximum value is 25.
• Change in Verbal Memory, Delayed Recall
  Time frame: Baseline and 12 weeks
  Delayed recall on the Logical Memory subset of the Wechsler Memory Scale-Revised, in which higher scores indicate a better recall and outcome. The minimum value is 0 and maximum value is 25.

Sponsor's own description

The purpose of this study is to determine the effects of oral estradiol and soy phytoestrogens on anxiety, stress responsivity and cognition in perimenopausal women.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.