Study to Evaluate the Effects of Synthetic Conjugated Estrogens, B (SCE-B) on Nocturnal Vasomotor Symptoms in Postmenopausal Women
A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of SCE-B on Nocturnal Vasomotor Symptoms in Postmenopausal Women
1 other identifier
interventional
157
1 country
17
Brief Summary
This is a multi-center study to evaluate the effects of SCE-B on nocturnal vasomotor symptoms. Study duration will be approximately 16 weeks; this includes a 4-week screening period and approximately 5 scheduled clinic visits. Participants will receive one of two strengths of SCE-B tablets plus matching placebo or placebo only, and will have a physical and gynecological exams that may include transvaginal ultrasound, endometrial biopsy and a pap smear. Participants will be asked to wear a monitoring device for a portion of the study and be asked to complete a daily dairy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2007
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 20, 2007
CompletedFirst Posted
Study publicly available on registry
January 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedResults Posted
Study results publicly available
March 17, 2010
CompletedJuly 19, 2013
July 1, 2013
1.2 years
December 20, 2007
February 4, 2010
July 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes
Change= Week 12 weekly average awakening score - Baseline weekly average awakening score for the intent-to-treat cohort
Baseline to End of Treatment (Week 12)
Secondary Outcomes (5)
Mean Change in Individual Sleep Parameters on a Three-point Scale
Baseline to End of Treatment (Week 12)
Mean Change in Stanford Sleepiness Scale
Baseline to End of Treatment (Week 12)
Mean Change in Biochemical Markers of Bone Metabolism (N-telopeptide).
From baseline to End of Treatment (Week 12)
Mean Change in Biochemical Markers of Bone Metabolism (Osteocalcin)
Baseline to End of Treatment (Week 12)
Mean Change in Biochemical Markers of Bone Metabolism (Sex Hormone Binding Globulin).
Baseline to End of Treatment (12 weeks)
Study Arms (3)
1
EXPERIMENTAL0.3 mg SCE-B Daily
2
EXPERIMENTAL0.625 mg SCE-B Daily
3
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Naturally or surgically menopausal
- Minimum 7 daily or 50 weekly moderate-to-severe hot flashes
You may not qualify if:
- Any contraindication to hormone therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duramed Researchlead
Study Sites (17)
Duramed Investigational Site
Anaheim, California, 92801, United States
Duramed Investigational Site
Sacramento, California, 95821, United States
Duramed Investigational Site
San Diego, California, 92108, United States
Duramed Investigational Site
Clearwater, Florida, 33759, United States
Duramed Investigational Site
West Palm Beach, Florida, 33409, United States
Duramed Investigational Site
Lexington, Kentucky, 40509, United States
Duramed Investigational Site
Louisville, Kentucky, 40291, United States
Duramed Investigational Site
Lincoln, Nebraska, 68510, United States
Duramed Investigational Site
Moorestown, New Jersey, 08057, United States
Duramed Investigational Site
Albuquerque, New Mexico, 87102, United States
Duramed Investigational Site
Winston-Salem, North Carolina, 27103, United States
Duramed Investigational Site
Cleveland, Ohio, 44122, United States
Duramed Investigational Site
Mayfield Heights, Ohio, 44124, United States
Duramed Investigational Site
Medford, Oregon, 97504, United States
Duramed Investigational Site
Pittsburgh, Pennsylvania, 15206, United States
Duramed Investigational Site
Columbia, South Carolina, 29201, United States
Duramed Investigational Site
San Antonio, Texas, 78229, United States
Related Publications (1)
Liu JH, Reape KZ, Hait HI. Synthetic conjugated estrogens-B and postmenopausal nocturnal vasomotor symptoms: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):78-84. doi: 10.1097/AOG.0b013e31823c0145.
PMID: 22183214DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Duramed Research Protocol Chair
- Organization
- Duramed Research
Study Officials
- STUDY CHAIR
Study Protocol Chair
Duramed Research, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2007
First Posted
January 14, 2008
Study Start
December 1, 2007
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
July 19, 2013
Results First Posted
March 17, 2010
Record last verified: 2013-07