NCT00184795 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Lundström E, Bygdeson M, Svane G, Azavedo E, von Schoultz B
Neutral effect of ultra-low-dose continuous combined estradiol and norethisterone acetate on mammographic breast density. Climacteric. 2007 Jun;10(3):249-56.
Panay N, Ylikorkala O, Archer DF, Gut R, Lang E
Ultra-low-dose estradiol and norethisterone acetate: effective menopausal symptom relief. Climacteric. 2007 Apr;10(2):120-31.
Sturdee DW, Archer DF, Rakov V, Lang E; CHOICE Study Investigators
. Ultra-low-dose continuous combined estradiol and norethisterone acetate: improved bleeding profile in postmenopausal women. Climacteric. 2008 Feb;11(1):63-73. doi: 10.1080/13697130701852

A Six Month Double-blind, Randomised, Parallel-group, Placebo-controlled, Multi-centre Trial to Investigate the Efficacy and Safety of Two Ultra-low Dose Combinations With 0.5 mg Estradiol and 0.1 mg or 0.25 mg Norethisterone Acetate (Activelle Low Dose 0.1/Activelle Low Dose 0.25) for Treatment of Menopausal Symptoms

Details for clinical trial NCT00184795

Clinical trial NCT00184795 - References