Research Investigation of Soy and Estrogen (RISE)

This study is currently recruiting participants.
Verified July 2010 by University of Illinois at Chicago
Sponsor:
Collaborator:
Information provided by:
University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT00997893
First received: October 18, 2009
Last updated: July 27, 2010
Last verified: July 2010
  Purpose

The purpose of this study is to examine the effects of soy (NovaSoy®) and estrogen on menopausal symptoms such as hot flashes, sleep disturbances, and mood alteration in perimenopausal women.


Condition Intervention Phase
Menopause
Hot Flashes
Dietary Supplement: Phytoestrogens
Drug: Estradiol
Drug: medroxyprogesterone acetate
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Estradiol and Soy on Menopausal Symptoms

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • quality of life [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 141
Study Start Date: December 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Estradiol Drug: Estradiol
Women in estradiol intervention group will take one active estradiol pill (1 mg) at breakfast and one placebo pill at dinner, for a total daily dose of 1 mg estradiol and 0 mg Novasoy®.
Other Name: estrogen, estradiol acetate
Drug: medroxyprogesterone acetate
At week 12 Day 2, after the participant completes her final assessments, women will begin taking MPA (10 mg/d for 10 days).
Other Name: MPA
Experimental: Phytoestrogen Dietary Supplement: Phytoestrogens
Women in the phytoestrogen intervention group will take one active Novasoy® (55 mg) pill at breakfast and active Novasoy® (55 mg) pill at dinner, for a total daily dose of 110 mg Novasoy® and 0 mg estradiol.
Other Name: NovaSoy 400
Other: Placebo
At week 12 Day 2, after the participant completes her final assessments, women will begin taking placebo(10 days).
Other Name: sugar pill
Placebo Comparator: Placebo Other: Placebo
Women in this intervention group will take one placebo pill at breakfast and one placebo pill at dinner, for a total daily dose of 0 mg Novasoy® and 0 mg estradiol.
Other Name: sugar pill
Other: Placebo
At week 12 Day 2, after the participant completes her final assessments, women will begin taking placebo(10 days).
Other Name: sugar pill

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • Perimenopausal as defined by the Stages of Reproductive Aging Workshop (STRAW) criteria, specifically in either of the two following stages: a) early transition defined as changes in cycle length of seven days or more in either direction in consecutive cycles or b) late transition defined as > 60 days amenorrhea and FSH > 40 IU/mL
  • Intact uterus/ovaries (i.e. no surgical menopause)
  • at least 1 self-reported hot flash per week
  • Estrogen therapy not contraindicated
  • Able to give informed consent
  • Age between 40 and 65 years
  • English as first and primary language

Exclusion Criteria:

  • Positive pregnancy test or breastfeeding (pregnancy tests will be given to all women)
  • Obesity > 33 BMI
  • Previous history of endometrial hyperplasia/neoplasia
  • Previous history of cancers of the breast or reproductive tract
  • History of presence of myocardial infarction (MI) or stroke
  • Current clinical diagnosis or a diagnosis within the past year of an anxiety disorder, severe recurrent depression, or severe psychiatric disturbance
  • History of head injury with more than 60 minutes loss of consciousness
  • History of neurological condition affecting cognitive function (e.g., brain tumor, multiple sclerosis)
  • History of developmental disability affecting cognitive function (e.g., mental retardation, attention deficit)
  • Current use of CNS-acting medication (e.g., antidepressants, anxiolytics, diphenhydramine)
  • History or presence of cerebrovascular accident, sickle cell anemia
  • History of alcohol or drug abuse as defined by DSM criteria
  • Abnormal vaginal bleeding of undetermined cause
  • Untreated or uncontrolled hypertension defined as systolic blood pressure greater than 165 mm hg or diastolic blood pressure greater than 95 mm hg
  • Concurrent administration of medication containing estrogen, progestin, SERM within four months of enrollment
  • Concurrent administration of medication containing St. John's wort, bisphosphonates, or dietary phytoestrogens within one month of enrollment
  • History of migraine associated with hormone use
  • History or presence of deep vein thrombosis, thrombophlebitis or thromboembolic disorder
  • Current participation in any other clinical trial within 30 days of enrollment
  • Smoker
  • Diabetes
  • Premature ovarian failure (defined as having last menstrual period before age 40)
  • Abnormal PAP smear in previous year
  • Abnormal mammogram in previous year
  • Vegans (vegetarians who tend to consume greater than average doses of phytoestrogens)
  • Allergy to soy (affects ~1% of people in the United States; reactions are typically mild)
  • Symptomatic fibroids (significant size or significant menstrual changes)
  • Menorrhagia
  • Lactose intolerant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997893

Contacts
Contact: Mary Winters, BS 312-355-5652 UIC.RISE.study@gmail.com

Locations
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Mary Winters, BS    312-355-5652    UIC.RISE.study@gmail.com   
Principal Investigator: Pauline M Maki, Ph.D.         
Sub-Investigator: Cheryl Carmin, Ph.D.         
Sub-Investigator: Stacie E. Geller, Ph.D., MPA         
Sub-Investigator: Sue Carter, Ph.D.         
Sub-Investigator: Stephen Porges, Ph.D.         
Sponsors and Collaborators
University of Illinois at Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: Pauline M. Maki, Ph. D., University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00997893     History of Changes
Other Study ID Numbers: 2009-0052, Snp 1 R01 MH083782-01
Study First Received: October 18, 2009
Last Updated: July 27, 2010
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
menopause
hot flashes
soy
estrogen
anxiety

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Estradiol
Polyestradiol phosphate
Estrogens
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Medroxyprogesterone
Medroxyprogesterone Acetate
Phytoestrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogens, Non-Steroidal

ClinicalTrials.gov processed this record on April 17, 2014