Study of Estradiol and Testosterone Hormonal Subdermal Implants to Treat Menopausal Symptoms in Women with Natural, Premature, or Surgical Menopause

What this Trial Is About

Researchers are studying menopausal women with estrogen and androgen deficiencies, including those with natural menopause, premature ovarian failure, or surgical menopause due to cervical cancer. The study evaluates the use of subdermal bioabsorbable implants of estradiol and testosterone to address menopausal and sexual symptoms. It is a phase 3 clinical trial assessing pharmacokinetic, biochemical, metabolic, thromboembolic, and hormonal effects, along with quality of life and sexual function changes. The trial involves 140 women divided into three groups postmenopausal women with symptoms, women under 40 with premature ovarian failure, and women with surgical menopause after hysterectomy for cervical cancer. Participants receive either a testosterone bioabsorbable implant 100 mg or a placebo pellet made of cholesterol. The study lasts six months, with follow-up visits at 1, 3, and 6 months post-implantation. Blood samples are collected at multiple time points to measure hormone levels and related biochemical markers. Participants will undergo questionnaires assessing quality of life, menopausal symptoms, and sexual function, along with general physical and gynecological exams and imaging tests. Hormonal, clinical, biochemical, and therapeutic parameters are evaluated at baseline, 3 months, and 6 months. Safety and treatment effects are analyzed statistically. The study focuses on measuring hormonal, metabolic, thromboembolic, and clinical impacts on climacteric symptoms over six months.

Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)