Research Investigation of Soy and Estrogen

NCT00997893 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2009-00525R01MH083782-05
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Menopause; Hot Flashes

Keywords

menopause; hot flashes; soy; estrogen; anxiety

Outcome Measures

Primary Outcomes (5)

• Change in STAI-6 Score

  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.

  Week 0, 10, 12, and 16-18

• Changes in STAI-6 Scores Before and After Psychosocial Stressor Over Time

  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.

  Baseline (Week 0) and Treatment (Week 12)

• Memory for Emotionally Valent Words and Neutral Words

  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.

  Baseline (Week 0) and Treatment (Week 12)

• Change in Verbal Memory, Immediate Recall

  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.

  Baseline and 12 weeks

• Change in Verbal Memory, Delayed Recall

  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.

  Baseline and 12 weeks

Study Arms (3)

Estradiol/Medroxyprogesterone Acetate

EXPERIMENTAL

1 mg/d oral Estradiol pill and 0 mg/d oral placebo pill for 12 weeks, followed by 10 mg/d oral medroxyprogesterone acetate (MPA) pill, for 10 days.

Drug: Estradiol; Drug: Medroxyprogesterone Acetate (MPA); Drug: Soy Placebo

Soy Phytoestrogen

EXPERIMENTAL

55 mg/twice daily oral Novasoy®/Soy Phytoestrogen pill for 12 weeks, followed by 0 mg/d oral placebo pill, for 10 days.

Dietary Supplement: Soy Phytoestrogen; Drug: MPA Placebo

Placebo

PLACEBO COMPARATOR

0 mg tablet/twice daily oral placebo pill for 12 weeks, followed by 0 mg/d oral placebo pill, for 10 days.

Drug: Soy Placebo; Drug: MPA Placebo

Interventions

Soy Phytoestrogen DIETARY_SUPPLEMENT

Novasoy® pill (55 mg)

Also known as: NovaSoy 400

Soy Phytoestrogen

Estradiol DRUG

Estradiol pill (1 mg)

Also known as: estrogen, estradiol acetate

Estradiol/Medroxyprogesterone Acetate

Medroxyprogesterone Acetate (MPA) DRUG

medroxyprogesterone acetate (MPA) (10mg)

Also known as: MPA

Estradiol/Medroxyprogesterone Acetate

Soy Placebo DRUG

oral placebo pill (0mg Soy Phytoestrogen)

Also known as: sugar pill

Estradiol/Medroxyprogesterone Acetate; Placebo

MPA Placebo DRUG

oral placebo pill (0mg MPA)

Also known as: sugar pill

Placebo; Soy Phytoestrogen

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Links

• UIC Department of Psychiatry Women's Mental Health Research Program Website

MeSH Terms

Conditions

Hot Flashes; Anxiety Disorders

Interventions

Estradiol; Estrogens; Medroxyprogesterone Acetate; Sugars

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Carbohydrates

Limitations and Caveats

Enrollment goals of 120 women were not met. Many declined to participate due to concerns about the safety of taking estrogens (the study was performed shortly after publication of the Women's Health Initiative) and due to the time commitment.

Results Point of Contact

• Title: Dr. Pauline Maki
• Organization: University of Illinois at Chicago

pmaki1@uic.edu

312 996-6941

Study Officials

• Pauline M Maki, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: October 18, 2009
• First Posted: October 19, 2009
• Study Start: December 1, 2009
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: December 7, 2020
• Results First Posted: December 7, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)