Status:
COMPLETED
Efficacy and Safety of Estradiol and Progesterone Microspheres for the Treatment of Climacteric Symptoms.
Lead Sponsor:
Centro A.F. de Estudios Tecnologicos, S.A.
Conditions:
Menopause
Eligibility:
FEMALE
40-65 years
Phase:
PHASE2
PHASE3
Brief Summary
During menopause a woman's body slowly produces less of the hormones estrogen and progesterone. Lower hormone levels in menopause may lead to hot flashes, vaginal dryness and osteoporosis. To help wit...
Detailed Description
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 develope...
Eligibility Criteria
Inclusion
- Age between 40 and 65 years.
- Perimenopausal subjects: Women showing spontaneous amenorrhea during the last 11 months.
- Postmenopausal subjects: Women with not less than 12 consecutive months of amenorrhea and FSH \> 40 mIU/mL
- Subjects showing vasomotor symptoms, not less than 3 hot flashes in a day or not less than 21 hot flashes in a week
- Healthy subjects determined on the basis of a satisfactory complete clinical history, clinical laboratory tests, cervical cytology, endometrium biopsy and vaginal pelvic ultrasonography.
- Subjects not receiving any hormonal treatment.
Exclusion
- Subjects with background of endometrial hyperplasia or endometrial cancer.
- Subjects with endometrial hyperplasia or endometrial cancer assessed by endometrial biopsy.
- Perimenopausal subjects with background of abnormal uterine bleeding unless the Principal Clinical Investigator considers that this abnormality is secondary to the menopausal condition.
- Subjects with hypersensitivity to any medicament.
- Subjects with direct family background of breast cancer.
- Subjects with background of cardiovascular disease, renal, hepatic, metabolic, gastrointestinal, neurologic, endocrine, gynecologic disease including dysfunctional uterine bleeding, cervico uterine dysplasia, cancer, anemia, emotional disorders, or any other chronic degenerative disorders which could affect her participation in the study.
- Subjects who require any medicament in the course of the study unless the Principal Clinical Investigator considers that there is no pharmacological interaction.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00775242
Start Date
April 1 2007
End Date
November 1 2008
Last Update
August 25 2009
Active Locations (1)
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1
Centro A.F. de Estudios Tecnologicos, S.A.
Mexico City, Mexico City, Mexico, 03100