Efficacy and Safety of Estradiol and Progesterone Microspheres for the Treatment of Climacteric Symptoms.
|ClinicalTrials.gov Identifier: NCT00775242|
Recruitment Status : Completed
First Posted : October 20, 2008
Last Update Posted : August 25, 2009
|Condition or disease||Intervention/treatment||Phase|
|Menopause||Drug: Estradiol and Progesterone||Phase 2 Phase 3|
Different formulations of estrogens and progestins have been used for the treatment of climacteric symptoms, however up to this date no formulation is completely satisfactory. Our company has developed a new technology for the preparation of controlled release bioerodible non-polymeric microspheres, these microspheres are capable of delivering doses of estradiol (E) and progesterone (P) at levels appropriate for the Hormonal Replacement Therapy (HRT) in order to relieve the climacteric symptoms. Non clinical and clinical studies have been conducted aimed at assessing the pharmacokinetics of these microspheres, at several doses of progesterone and estradiol. Results show that sustained plasma profiles for both steroids within the therapeutic range for several days are attained. On this basis, a new efficacy and safety study is going to be conducted with the purpose of assessing and defining the most appropriate doses of estradiol and progesterone for the HRT of the climacteric symptoms.
Three different doses of progesterone and estradiol (0.5 mg of E + 15 mg of P vs 1 mg of E + 20 mg of P vs 1 mg of E + 30 mg of P) will be compared in terms of their efficacy and safety to treat the climacteric symptoms in healthy postmenopausal women.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparative Efficacy and Safety Study of Three Different Doses of a Formulation Composed of Crystalline Estradiol and Progesterone Microspheres, Indicated for Monthly IM Injection for the Treatment ot Climacteric Symptoms.|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
Experimental: Estradiol and progesterone injection
Comparison of three different dosages of estradiol and progesterone a) 0.5 mg E/15 mg P; b) 1 mg E/20 mg P; c) 1 mg E/30 mg P
Drug: Estradiol and Progesterone
Injectable suspension of three different dosages of estradiol and progesterone a) 0.5 mg E/15 mg P; b) 1 mg E/20 mg P; c) 1 mg E/30 mg P. Administered on a monthly basis during a six-month period.
Other Name: estrogens and progestinesDrug: Estradiol and Progesterone
Injectable suspension of three different formulations of estradiol and progesterone a) 0.5 mg E/15 mg P; b) 1 mg E/20 mg P; c) 1 mg E/30 mg P. Each will be applied on a monthly basis during a six-month period
- Change of frequency and intensity of vasomotor symptoms [ Time Frame: 0, 1, 2, 3, 4, 5, 6 and 7 months ]
- Frequency and intensity of vulvar and vaginal atrophy symptoms Vaginal pH Index of vaginal maturation (surface, intermediate and parabasal cells) Karyopiknotic index Lipids profile Utian quality of life scale Green climacteric symptoms scale [ Time Frame: 0, 1, 2, 3, 4, 5, 6 and 7 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00775242
|Centro A.F. de Estudios Tecnologicos, S.A.|
|Mexico, DF, Mexico, 03100|
|Principal Investigator:||Manuel Cortes Bonilla, Ob/Gyn|