Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Research Investigation of Soy and Estrogen (RISE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Illinois at Chicago
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Pauline M. Maki, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT00997893
First received: October 18, 2009
Last updated: May 6, 2014
Last verified: May 2014
  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: Phytoestrogen
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 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Estradiol/Medroxyprogesterone Acetate

Women in estradiol intervention group will take one active estradiol pill (1 mg) and one placebo pill at dinner, for a total daily dose of 1 mg estradiol and 0 mg Novasoy®. The UIC investigational drug service will obtain the estradiol tablets through the regular Hospital Pharmacy Purchases vendor, will encapsulate them, and will manufacture an identical appearing placebo to maintain blind.

Medroxyprogesterone acetate (MPA): The UIC IDS will dispense MPA (10 mg/d for 10 days) at the time of randomization. This progestin treatment is necessary to protect the uterine lining. These pills will be encapsulated in order to maintain blind .

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 , after the participant completes her final assessments, women will begin taking MPA (10 mg/d for 10 days).
Other Name: MPA
Experimental: Phytoestrogen
Phytoestrogen: 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. The UIC Investigational Drug Service will obtain the Novasoy® tablets from Archer Daniels Midland and will encapsulate the tablets to maintain blind.
Dietary Supplement: Phytoestrogen
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, after the participant completes her final assessments, women will begin taking placebo(10 days).
Other Name: sugar pill
Placebo Comparator: Placebo
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. The UIC investigational drug service will encapsulate the placebo tablets (lactose) in the same manner that they will encapsulate the estradiol and Novasoy® tablets to maintain blind.
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, after the participant completes her final assessments, women will begin taking placebo(10 days).
Other Name: sugar pill

  Show Detailed Description

  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 > 35 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997893

Contacts
Contact: Katie D'Aunno, 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: Katie D'Aunno, 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
Investigators
Principal Investigator: Pauline M Maki, PhD 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, 5R01MH083782-05
Study First Received: October 18, 2009
Last Updated: May 6, 2014
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
Contraceptives, Oral
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Estrogens
Medroxyprogesterone
Medroxyprogesterone Acetate
Phytoestrogens
Polyestradiol phosphate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Contraceptives, Oral, Synthetic
Estrogens, Non-Steroidal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014