Phase 4
N=157
Study to Evaluate the Effects of Synthetic Conjugated Estrogens, B (SCE-B) on Nocturnal Vasomotor Symptoms in Postmenopausal Women
Nocturnal Vasomotor Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT00592839 ↗Enrolled (actual)
157
Serious AEs
0.6%
Results posted
Mar 2010
Primary outcome: Primary: Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes — -19.54; -20.55; -15.99 Awakenings
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- SCE-B (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- Female
- Sponsor
- Duramed Research
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes |
-19.54; -20.55; -15.99 | — |
| SECONDARY Mean Change in Individual Sleep Parameters on a Three-point Scale |
0.54; 0.56; 0.47 | — |
| SECONDARY Mean Change in Stanford Sleepiness Scale |
-0.79; -0.44; -0.62 | — |
| SECONDARY Mean Change in Biochemical Markers of Bone Metabolism (N-telopeptide). |
-1.1; -3.8; -0.6 | — |
| SECONDARY Mean Change in Biochemical Markers of Bone Metabolism (Osteocalcin) |
-3.7; -4.4; -0.3 | — |
| SECONDARY Mean Change in Biochemical Markers of Bone Metabolism (Sex Hormone Binding Globulin). |
19.5; 44.8; -3.3 | — |
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
Data sourced from ClinicalTrials.gov (NCT00592839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.