drugset / Trial / NCT00446199
Low-dose Hormone Therapy for Relief of Vasomotor Symptoms
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2007-03
- Primary completion
- 2008-10
- Completion
- 2008-11
Outcome
Met primary endpoint
paper All active treatments were significantly more effective than placebo for the primary efficacy variables for drospirenone/17β-estradiol (P < 0.0001) PMID 23963307 ↗
paper All active treatments were significantly more effective than placebo for the primary efficacy variables for drospirenone/17β-estradiol (P < 0.0001), and for 17β-estradiol (P < 0.01) at 4 and 12 weeks. PMID 23963307 ↗
Publications
- Results 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.
- Results 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.
- Results 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
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Estradiol | Other / unclassified | 0.3 mg | Oral |
| Subject | Estradiol | Other / unclassified | 0.5 mg | Oral |
| Subject | drospirenone | Unknown | 0.25 mg | Oral |
| Subject | drospirenone | Unknown | 0.5 mg | Oral |
Indications
No indication recorded.