Efficacy and Safety of Estradiol and Progesterone Microspheres for the Treatment of Climacteric Symptoms.

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: Female

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 with these problems, women are often given estrogen or estrogen with progestin. The purpose of this study is to assess and compare the efficacy and safety of three doses of estradiol and progesterone for the treatment of the climacteric symptoms

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro A.F. de Estudios Tecnologicos, S.A.
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Polyestradiol phosphate; Progesterone; Progestins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.