Oral Estrogen use in treatment of women with Acromegaly

Phase 2

Recruiting

• Conditions: C04.557.470.035.415; C10.228.140.617.738; C04.588.322.609; Study conducted: women with disease: Acromegaly.Target population: Female (childbearing age), volunteers of the intervention female with uncontrolled Acromegaly. Medicine: formulation oral of ethynil estradiol 0.03mg + levonorgestrel 0.15mg. Acromegaly, Growth Hormone-Secreting Pituitary Adenoma, pituitary disease, pituitary neoplasms.; E22.0

• Registration Number: RBR-4n5mkh
• Lead Sponsor: Instituto Estadual do Cerebro Paulo Niemeyer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Patients of childbearing age who had a desire for contraception and who agreed to use oral contraceptives were included. All participants were uncontrolled with IGF-I concentration above the upper limit of normal range (ULNR) for age, and with a random GH level above 1 ng/ml.

Exclusion Criteria

The study exclusion criteria included contraindications to oral contraceptive use such as cerebrovascular or coronary artery disease; history of deep vein thrombosis, pulmonary embolism, or congestive heart failure; untreated or uncontrolled hypertension (relative contraindication: systolic blood pressure 140-159 or diastolic 90-99; absolute: ? 160mmHg or ? 100mmHg); breast cancer; estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, known or suspected pregnancy, benign or malignant liver tumors; active liver disease; smoking; diabetes with vascular complications; renal failure with glomerular filtration rate below 30ml/min.

Study & Design

• Study Type: Intervention
• Study Design: Not specified