Clinical trial NCT00592839: Study to Evaluate the Effects of Synthetic Conjugated Estrogens, B (SCE-B) on Nocturnal Vasomotor Symptoms in Postmenopausal Women
Official title: A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of SCE-B on Nocturnal Vasomotor Symptoms in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nocturnal Vasomotor Symptoms
Keywords: Nocturnal vasomotor symptoms in postmenopausal women
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2008-01-14
Enrollment: 157
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Naturally or surgically menopausal
* Minimum 7 daily or 50 weekly moderate-to-severe hot flashes

Exclusion Criteria:

* Any contraindication to hormone therapy

Primary outcomes:
measure: Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes
timeFrame: Baseline to End of Treatment (Week 12)
Secondary outcomes:
measure: Mean Change in Individual Sleep Parameters on a Three-point Scale
timeFrame: Baseline to End of Treatment (Week 12)
measure: Mean Change in Stanford Sleepiness Scale
timeFrame: Baseline to End of Treatment (Week 12)
measure: Mean Change in Biochemical Markers of Bone Metabolism (N-telopeptide).
timeFrame: From baseline to End of Treatment (Week 12)
measure: Mean Change in Biochemical Markers of Bone Metabolism (Osteocalcin)
timeFrame: Baseline to End of Treatment (Week 12)
measure: Mean Change in Biochemical Markers of Bone Metabolism (Sex Hormone Binding Globulin).
timeFrame: Baseline to End of Treatment (12 weeks)
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Duramed Investigational Site
state: California
city: Sacramento
country: United States
facility: Duramed Investigational Site
state: California
city: San Diego
country: United States
facility: Duramed Investigational Site
state: California
city: Clearwater
country: United States
facility: Duramed Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Duramed Investigational Site
state: Florida
city: Lexington
country: United States
facility: Duramed Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Duramed Investigational Site
state: Kentucky
city: Lincoln
country: United States
facility: Duramed Investigational Site
state: Nebraska
city: Moorestown
country: United States
facility: Duramed Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Duramed Investigational Site
state: New Mexico
city: Winston-Salem
country: United States
facility: Duramed Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Mayfield Heights
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Medford
country: United States
facility: Duramed Investigational Site
state: Oregon
city: Pittsburgh
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: Duramed Investigational Site
state: South Carolina
city: San Antonio
country: United States
facility: Duramed Investigational Site
state: Texas
Study officials:
affiliation: Duramed Research, Inc.
name: Study Protocol Chair
role: STUDY_CHAIR
References:
citation: 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.