Pharmacokinetic, Clinical, Hormonal and Therapeutic Effects of the Use of Estradiol and Testosterone Hormonal Subdermal Implants in Women With Natural Menopause, Premature Ovarian Failure or Surgical Menopause Due to Cervical Cancer.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Estrogen and androgen deficiencies negatively impact the quality of life of women at different stages of life, especially after menopause. New modalities and new therapeutic alternatives have been researched. Parenteral administration of estradiol and testosterone could be effective to treat symptoms secondary to estrogen and androgen deficiencies and minimize these adverse events. This study evaluates the efficiency of subdermal implant-bioabsorbable use in women with menopausal symptoms associated with secondary estrogen and androgen deficiencies in women with natural menopause, premature ovarian failure or surgical menopause due to cervical cancer. Pharmacokinetic, biochemical, metabolic, thromboembolic and hormonal data will be evaluated, as well as the effects on quality of life, menopausal symptoms and sexual function after treatment.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• menopause time of 2 to 6 years;

• Body Mass Index between 25 and 30 kg/m2;

• women hysterectomized and ovariectomized due to cervical cancer;

• women with premature ovarian failure and under 40 years of age;

• active sex life;

• absence of severe depression and anxiety, confirmed by evaluation using the Beck (specific for depression) and Beck (specific for anxiety) questionnaires.

Locations
Other Locations
Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
RECRUITING
São Paulo
Contact Information
Primary
André Malavasi, PhD
drandreluiz@usp.br
55 11 981348231
Backup
Edmund Baracat, PhD
55 11 98149-6253
Time Frame
Start Date: 2025-12-18
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 140
Treatments
Active_comparator: Testosterone
Subdermal implant-bioabsorbable testosterone pellet (100 mg of testosterone)
Placebo_comparator: Placebo
Subdermal implant-bioabsorbable placebo pellet (cholesterol)
Sponsors
Leads: University of Sao Paulo General Hospital

This content was sourced from clinicaltrials.gov