Treatment of menopausal symptoms with three low-dose continuous sequential 17β-estradiol/progesterone parenteral monthly formulations using novel non-polymeric microsphere technology
| Autor: | María Teresa de Jesús Francisco-Doce, Manuel Cortés-Bonilla, Roberto Bernardo-Escudero, Rosalba Alonso-Campero, Cuauhtémoc Celis-González, Marcelino Hernández-Valencia, Juan A. Uribe, Ricardo Márquez-Oñate, Peter Chedraui |
|---|---|
| Rok vydání: | 2015 |
| Předmět: |
Adult
medicine.medical_specialty Hormone Replacement Therapy Endocrinology Diabetes and Metabolism vasomotor symptoms menopause progesterone Gastroenterology Injections Intramuscular Group B Endocrinology Atrophy Internal medicine medicine Humans Single-Blind Method Gynecology Estradiol injectable estradiol Genitourinary system business.industry Estrogen Replacement Therapy Obstetrics and Gynecology Middle Aged medicine.disease Female Urogenital Diseases Microspheres Menopause Treatment Outcome Hot Flashes Hormonal therapy Histopathology Amenorrhea Female Original Article medicine.symptom Intramuscular injection business |
| Zdroj: | Gynecological Endocrinology |
| ISSN: | 1473-0766 |
| Popis: | Objective: To analyze the short-term efficacy and safety over menopausal symptoms of three low-dose continuous sequential 17β-estradiol (E)/progesterone (P) parental monthly formulations using novel non-polymeric microspheres. Methods: This was a multicenter, randomized, single blinded study in which peri- and postmenopausal women were assigned to receive a monthly intramuscular injection of 0.5 mg E + 15 mg P (Group A, n = 34), 1 mg E + 20 mg P (Group B, n = 24) or 1 mg E + 30 mg P (Group C, n = 26) for 6 months. Primary efficacy endpoints included mean change in the frequency and severity of hot flushes and the effect over urogenital atrophy symptoms at 3 and 6 months. Safety variables included changes in the rate of amenorrhea, endometrial thickness and histopathology, and local and systemic adverse events. Results: Compared to baseline at month 6, the three treatment schemes significantly decreased the rate of urogenital atrophy symptoms and the frequency (mean number per day) and severity (mean number graded as moderate and severe per month) of hot flushes. No differences in studied efficacy parameters were observed between studied groups at baseline or at the end of the study. For all groups the most frequent adverse event was pain at the injection site; however they were all rated as mild. At the end of the study peri- and postmenopausal women displayed no significant changes in endometrial thickness or histopathology in all treated groups. The rate of amenorrhea at the end of the study decreased for all studied groups yet was less evident among postmenopausal women as compared to perimenopausal ones. Conclusions: The three low-dose continuous sequential intramuscular monthly treatments of E/P using novel microsphere technology were effective at reducing menopausal symptoms at short-term with a low rate of adverse events. More long-term and comparative research is warranted to support our positive findings. |
| Databáze: | OpenAIRE |
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