Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06343870
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-18
Brief Title:
Estradiol and Testosterone Subdermal Implants for Menopause Treatment ESTIME
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESTIME
Brief 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
Detailed Description:
The clinical study will be carried out on 140 women who will be divided into three groups 1 postmenopausal women with menopausal and sexual symptoms n60 2 women with premature ovarian failure n40 3 women with cervical cancer undergoing abdominal hysterectomy with bilateral adnexectomy with menopausal and sexual symptoms n40
All participants will answer questionnaires to assess quality of life menopausal symptoms and sexual function All participants will undergo general physical and gynecological examinations as well as hormonal biochemical thromboembolic and imaging tests
The study will last six months The included participants will undergo the following visits inclusion post-selection and 1 3 and 6 months after implant insertion For the pharmacokinetic study blood samples will be collected at the following periods inclusion before implant placement and after 1h 2h 3h 6h and 12h one week two weeks and one month after placement and then monthly until six months after implant insertion to evaluate serum levels of Luteinizing hormone Follicle stimulating hormone estradiol estrone total testosterone and sex hormone-binding globulin
Clinical biochemical hormonal and therapeutic parameters will be evaluated before placement inclusion and after 3 and 6 months The Mann Whitney test will be applied to evaluate differences between measurements and the chi-square test will be applied to analyze the proportions of improvement between groups before and after treatment
All participants will answer questionnaires to assess quality of life menopausal symptoms and sexual function All participants will undergo general physical and gynecological examinations as well as hormonal biochemical thromboembolic and imaging tests
The study will last six months The included participants will undergo the following visits inclusion post-selection and 1 3 and 6 months after implant insertion For the pharmacokinetic study blood samples will be collected at the following periods inclusion before implant placement and after 1h 2h 3h 6h and 12h one week two weeks and one month after placement and then monthly until six months after implant insertion to evaluate serum levels of Luteinizing hormone Follicle stimulating hormone estradiol estrone total testosterone and sex hormone-binding globulin
Clinical biochemical hormonal and therapeutic parameters will be evaluated before placement inclusion and after 3 and 6 months The Mann Whitney test will be applied to evaluate differences between measurements and the chi-square test will be applied to analyze the proportions of improvement between groups before and after treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None