Pharmacokinetic Aspects of 25-mg Estradiol Pellet in Climacteric Women
NCT ID: NCT06136208
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2023-12-13
2025-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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s.c 25 mg estradiol pellet
Subcutaneous insertion of 25 mg estradiol pellet.
Eligibility Criteria
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Inclusion Criteria
* Woman aged ≥ 41 and ≤ 59 years
* Weight ≥ 50 kg and ≤ 98 kg
* BMI ≥ 18.5 and ≤ 34.9 kg/m²
* Hysterectomy (with or without oophorectomy)
* Serum total estradiol concentration ≤ 50 pg/mL and serum FSH concentration ≥ 25 mIU/mL, both determined by immunoassays
* Presence of menopause-associated symptoms
* Absence of signs and symptoms and propedeutics suggestive of breast cancer evidenced by mammography report (woman aged \> 40 years) for less than 12 months = BI-RADS1 or BI-RADS2
* Agreement not to use other hormones (estrogens, androgens and/or progestogens) in any pharmaceutical form during the study
Exclusion Criteria
* Comorbidities associated with increased cardiovascular risk: smoking, uncontrolled diabetes, dyslipidemia, and uncontrolled hypertension
* Serious chronic disorders, including metastatic malignancies, kidney disease in the end-stage with or without dialysis, clinically unstable heart disease, or any another disorder that, in the opinion of the investigator, excludes the participant from the study
* Immunocompromise or suspected or confirmed diagnosis of immunodeficiency based on history and/or physical or laboratory examination
* Active liver disease or dysfunction
* Benign or malignant tumors of the liver
* Clinical diagnosis of polycystic ovary syndrome
* Use of other hormones (estrogens, androgens and/or progestogens) in any pharmaceutical form in the last month
* Current use of drugs that alter cytochrome P450 and metabolization of Estrogens
* Current use of tamoxifen, aromatase inhibitors, or agonists/antagonists GnRH for cancer or any other condition
* Current use of phytoestrogens
* Participation in another clinical study within 30 days prior to the start of the Study treatment
41 Years
59 Years
FEMALE
Yes
Sponsors
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Biòs Farmacêutica
UNKNOWN
Science Valley Research Institute
OTHER
Responsible Party
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Principal Investigators
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André Luiz Malavasi de Oliveira Longo, MD, PhD
Role: STUDY_CHAIR
Science Valley Research Institute
Locations
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Irmandade Da Santa Casa De Misericórdia De Santos - Science Valley Research Center
Santos, São Paulo, Brazil
Countries
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References
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Casals G, Costa RF, Rull EU, Escobar-Morreale HF, Argente J, Sesmilo G, Biagetti B. Recommendations for the measurement of sexual steroids in clinical practice. A position statement of SEQCML/SEEN/SEEP. Adv Lab Med. 2023 Mar 9;4(1):52-69. doi: 10.1515/almed-2023-0020. eCollection 2023 Apr.
del Carmen Cravioto M, Larrea F, Delgado NE, Escobar AR, Diaz-Sanchez V, Dominguez J, de Leon RP. Pharmacokinetics and pharmacodynamics of 25-mg estradiol implants in postmenopausal Mexican women. Menopause. 2001 Sep-Oct;8(5):353-60. doi: 10.1097/00042192-200109000-00010.
Hamoda H, Panay N, Pedder H, Arya R, Savvas M. The British Menopause Society & Women's Health Concern 2020 recommendations on hormone replacement therapy in menopausal women. Post Reprod Health. 2020 Dec;26(4):181-209. doi: 10.1177/2053369120957514. Epub 2020 Oct 12. No abstract available.
Kuhl H. Pharmacology of estrogens and progestogens: influence of different routes of administration. Climacteric. 2005 Aug;8 Suppl 1:3-63. doi: 10.1080/13697130500148875.
Lobo RA, March CM, Goebelsmann U, Krauss RM, Mishell DR Jr. Subdermal estradiol pellets following hysterectomy and oophorectomy. Effect upon serum estrone, estradiol, luteinizing hormone, follicle-stimulating hormone, corticosteroid binding globulin-binding capacity, testosterone-estradiol binding globulin-binding capacity, lipids, and hot flushes. Am J Obstet Gynecol. 1980 Nov 15;138(6):714-9.
Lobo RA. Hormone-replacement therapy: current thinking. Nat Rev Endocrinol. 2017 Apr;13(4):220-231. doi: 10.1038/nrendo.2016.164. Epub 2016 Oct 7.
Manson JE, Bassuk SS, Kaunitz AM, Pinkerton JV. The Women's Health Initiative trials of menopausal hormone therapy: lessons learned. Menopause. 2020 Aug;27(8):918-928. doi: 10.1097/GME.0000000000001553.
Notelovitz M, Johnston M, Smith S, Kitchens C. Metabolic and hormonal effects of 25-mg and 50-mg 17 beta-estradiol implants in surgically menopausal women. Obstet Gynecol. 1987 Nov;70(5):749-54.
Owen EJ, Siddle NC, McGarrigle HT, Pugh MA. 25 mg oestradiol implants--the dosage of first choice for subcutaneous oestrogen replacement therapy? Br J Obstet Gynaecol. 1992 Aug;99(8):671-5. doi: 10.1111/j.1471-0528.1992.tb13853.x.
Stanczyk FZ, Shoupe D, Nunez V, Macias-Gonzales P, Vijod MA, Lobo RA. A randomized comparison of nonoral estradiol delivery in postmenopausal women. Am J Obstet Gynecol. 1988 Dec;159(6):1540-6. doi: 10.1016/0002-9378(88)90591-1.
Stuenkel CA, Davis SR, Gompel A, Lumsden MA, Murad MH, Pinkerton JV, Santen RJ. Treatment of Symptoms of the Menopause: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015 Nov;100(11):3975-4011. doi: 10.1210/jc.2015-2236. Epub 2015 Oct 7.
Suhonen SP, Allonen HO, Lahteenmaki P. Sustained-release subdermal estradiol implants: a new alternative in estrogen replacement therapy. Am J Obstet Gynecol. 1993 Nov;169(5):1248-54. doi: 10.1016/0002-9378(93)90291-p.
Thom MH, Collins WP, Studd JW. Hormonal profiles in postmenopausal women after therapy with subcutaneous implants. Br J Obstet Gynaecol. 1981 Apr;88(4):426-33. doi: 10.1111/j.1471-0528.1981.tb01008.x.
Other Identifiers
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CLARA Study
Identifier Type: -
Identifier Source: org_study_id
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