Low-dose Hormone Therapy for Relief of Vasomotor Symptoms

NCT00446199 | Completed Phase 3 Results

• 2 other identifiers: 91493310184
• Study Type: interventional
• Target: 735
• Locations: 1 country
• Sites: 76

Brief Summary

The purpose of this study is to determine the lowest effective dose of the study drug for the relief of moderate to severe vasomotor symptoms in postmenopausal women for 12 weeks.

Conditions

Vasomotor Symptoms; Hot Flashes

Keywords

Vasomotor symptom relief; Postmenopausal women; Severe to Moderate Vasomotor symptoms

Outcome Measures

Primary Outcomes (4)

• Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)

  Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 12 number of moderate to severe hot flushes minus baseline number.

  Baseline until 12 weeks of treatment

• Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)

  Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 4 number of moderate to severe hot flushes minus baseline number.

  Baseline until 4 weeks of treatment

• Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)

  Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as \[(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)\] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 12 severity of moderate to severe hot flushes minus baseline severity.

  Baseline until 12 weeks of treatment

• Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)

  Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as \[(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)\] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 4 severity of moderate to severe hot flushes minus baseline severity.

  Baseline until 4 weeks of treatment

Secondary Outcomes (10)

• Change From Baseline to Week 12 in Vaginal pH

  Baseline until 12 weeks of treatment

• Change From Baseline to Week 12 in Vaginal Maturation Value

  Baseline until 12 weeks of treatment

• Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Dryness'

  After 12 weeks of treatment

• Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal and/or Vulvar Irritation/Itching'

  After 12 weeks of treatment

• Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Dysuria'

  After 12 weeks of treatment

Other Outcomes (4)

• Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Mean Value)

  Baseline until 12 weeks of treatment

• Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Mean Value)

  Baseline until 4 weeks of treatment

• Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Mean Value)

  Baseline until 12 weeks of treatment

Study Arms (4)

0.5mg DRSP / 0.5mg E2 (BAY86-4891)

EXPERIMENTAL

One tablet \[0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle).

Drug: 0.5mg DRSP / 0.5mg E2 (BAY86-4891)

0.25mg DRSP / 0.5mg E2 (BAY86-4891)

EXPERIMENTAL

One tablet \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle).

Drug: 0.25mg DRSP / 0.5mg E2 (BAY86-4891)

Estradiol (E2 0.3mg)

EXPERIMENTAL

One tablet \[17β-estradiol (E2 0.3mg)\] per day taken orally for 3 cycles (28 days per cycle).

Drug: Estradiol (E2 0.3mg)

Placebo

PLACEBO COMPARATOR

Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

Drug: Placebo

Interventions

0.5mg DRSP / 0.5mg E2 (BAY86-4891) DRUG

One tablet \[0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle).

0.5mg DRSP / 0.5mg E2 (BAY86-4891)

0.25mg DRSP / 0.5mg E2 (BAY86-4891) DRUG

One tablet \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle).

0.25mg DRSP / 0.5mg E2 (BAY86-4891)

Estradiol (E2 0.3mg) DRUG

One tablet \[17β-estradiol (E2 0.3mg)\] per day taken orally for 3 cycles (28 days per cycle).

Estradiol (E2 0.3mg)

Placebo DRUG

Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

Placebo

Eligibility Criteria

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

You may qualify if:

• \- Postmenopausal women \>40 years of age experiencing a minimum of 7 to 8 moderate to severe hot flushes per day or 50 to 60 moderate to severe hot flushes per week

You may not qualify if:

• Intake of medications other than hormones affecting hot flushes

Sponsors & Collaborators

• Bayer: lead

Study Sites (76)

Unknown Facility

Mobile, Alabama, 36608, United States

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Chandler, Arizona, 85225, United States

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Phoenix, Arizona, 85031, United States

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Tucson, Arizona, 85712, United States

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Tucson, Arizona, 85741, United States

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Little Rock, Arkansas, 72205, United States

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Paramount, California, 90723, United States

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San Diego, California, 92103, United States

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San Diego, California, 92108, United States

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San Diego, California, 92121, United States

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San Diego, California, 92123, United States

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Valley Village, California, 91607, United States

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Vista, California, 92083, United States

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Colorado Springs, Colorado, 80910, United States

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Denver, Colorado, 80218, United States

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New Britain, Connecticut, 06050, United States

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Boynton Beach, Florida, 33437, United States

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Clearwater, Florida, 33761, United States

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Daytona Beach, Florida, 32114, United States

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Fort Myers, Florida, 33916, United States

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Jacksonville, Florida, 32216, United States

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Lake Worth, Florida, 33461, United States

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Leesburg, Florida, 34748, United States

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Miami, Florida, 33169, United States

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Miami, Florida, 33186, United States

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New Port Richey, Florida, 34655, United States

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Tampa, Florida, 33607, United States

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West Palm Beach, Florida, 33409, United States

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Atlanta, Georgia, 30328, United States

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Atlanta, Georgia, 30342, United States

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Decatur, Georgia, 30034, United States

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Boise, Idaho, 83702, United States

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Idaho Falls, Idaho, 83404, United States

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Arlington Heights, Illinois, 60004, United States

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Champaign, Illinois, 61820, United States

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La Grange Park, Illinois, 60526, United States

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Newburgh, Indiana, 47630, United States

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Lexington, Kentucky, 40536, United States

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Amite, Louisiana, 70422, United States

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Marrero, Louisiana, 70072, United States

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Paw Paw, Michigan, 49079, United States

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Chaska, Minnesota, 55318, United States

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Springfield, Missouri, 65802, United States

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Billings, Montana, 59101, United States

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Billings, Montana, 59102, United States

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Lincoln, Nebraska, 68510, United States

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Las Vegas, Nevada, 89104, United States

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Reno, Nevada, 89502, United States

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Lawrenceville, New Jersey, 08648, United States

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New Brunswick, New Jersey, 08901, United States

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Princeton, New Jersey, 08540, United States

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Albuquerque, New Mexico, 87102, United States

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Raleigh, North Carolina, 27612, United States

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Winston-Salem, North Carolina, 27103, United States

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Fargo, North Dakota, 58105, United States

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Cleveland, Ohio, 44122, United States

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Columbus, Ohio, 43213, United States

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Oklahoma City, Oklahoma, 73103, United States

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Tulsa, Oklahoma, 74105, United States

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Erie, Pennsylvania, 16502, United States

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Philadelphia, Pennsylvania, 19114, United States

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Pittsburgh, Pennsylvania, 15206, United States

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Wexford, Pennsylvania, 15090, United States

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Columbia, South Carolina, 29201, United States

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Sioux Falls, South Dakota, 57105, United States

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Chattanooga, Tennessee, 37403, United States

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Chattanooga, Tennessee, 37404, United States

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Memphis, Tennessee, 38120, United States

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Dallas, Texas, 75234, United States

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Houston, Texas, 77004, United States

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Houston, Texas, 77030, United States

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Burlington, Vermont, 05401, United States

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Norfolk, Virginia, 23507, United States

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Richmond, Virginia, 23294, United States

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Renton, Washington, 98055, United States

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Seattle, Washington, 98105, United States

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Related Publications (4)

• Sutter G, Schmelter T, Gude K, Schaefers M, Gerlinger C, Archer DF. Population pharmacokinetic/pharmacodynamic evaluation of low-dose drospirenone with 17beta-estradiol in postmenopausal women with moderate to severe vasomotor symptoms. Menopause. 2014 Mar;21(3):236-42. doi: 10.1097/GME.0b013e31829c12e8.

  PMID: 23963309 RESULT

• Archer DF, Schmelter T, Schaefers M, Gerlinger C, Gude K. A randomized, double-blind, placebo-controlled study of the lowest effective dose of drospirenone with 17beta-estradiol for moderate to severe vasomotor symptoms in postmenopausal women. Menopause. 2014 Mar;21(3):227-35. doi: 10.1097/GME.0b013e31829c1431.

  PMID: 23963307 RESULT

• K. Gude; T. Schmelter; M. Schaefers; C. Gerlinger. Efficacy of low dose Angeliq (0.5 mg E2 and 0.25 or 0.5 mg DRSP) compared to Angeliq (1 mg E2 and 1, 2 or 3 mg DRSP) in postmenopausal women with moderate to severe hot flushes. Menopause, Vol. 19, No. 12, 2012 * 2012, P-36, p 1388

  RESULT

• Gerlinger C, Gude K, Hiemeyer F, Schmelter T, Schafers M. An empirically validated responder definition for the reduction of moderate to severe hot flushes in postmenopausal women. Menopause. 2012 Jul;19(7):799-803. doi: 10.1097/gme.0b013e31823de8ba.

  PMID: 22228322 DERIVED

MeSH Terms

Conditions

Hot Flashes

Interventions

drospirenone; Estradiol

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2007
• First Posted: March 12, 2007
• Study Start: March 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: November 1, 2008
• Last Updated: May 6, 2015
• Results First Posted: April 18, 2012

Record last verified: 2015-04

Locations

US (76)