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.
Conditions
Interventions
Nine patients with uncontrolled acromegaly in the study, median age was 35 years (26-42).
Prospective study, interventionist, single arm and single group, in which clinical, radiological and biochemi
assess the percentage of patients with acromegaly who have normalized IGF-I levels with the use of oral estrogen
evaluate the percentage of reduction of IGF-I levels with treatment with oral estrogen
assess the safety of using oral estrogen in patients with acromegaly
evaluate the radiological response analyzed by the Turkish saddle magnetic resonance: through the tumor size, volume and tumor invasion based on the Knosp classification.
Drug
C05.116.132.082
D12.644.276.937.400
D04.210.500.668.651.568.291
E02.875.194.573
D12.776.826.750.350.174
Sponsors
Instituto Estadual do Cerebro Paulo Niemeyer
Universidade Federal do Rio de Janeiro
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our study aimed to evaluate the effect of oral estrogen use in young patients with acromegaly of childbearing age with uncontrolled acromegaly. In our study, patients will be evaluated that responded to oral estrogen with median reduction in IGF-I. ;Response to treatment was analyzed biochemically with reduction and / or normalization of IGF-I and radiologically with tumor response based on magnetic resonance imaging after 6 months of oral estrogen. ;To evaluate the efficacy of oral estrogen therapy in female patients of childbearing age with uncontrolled acromegaly and to correlate biochemical and radiological responses with presence of estrogen receptor alpha (ER-alpha) in the somatotropinoma.;Complete biochemical control with estrogen treatment was defined as GH level <1 ng/ml and normal IGF-I level adjusted for age. Partial response to estrogen treatment was defined as IGF-I reduction but no normalization. Non-responders were defined as stable IGF-I or increase in IGF-I after 6 months of oral estrogen use. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the therapy and efficacy of using oral estrogen in female patients of reproductive age with uncontrolled acromegaly. To evaluate the response of patients with acromegaly who received oral estrogen therapy in addition to conventional treatment. To evaluate the percentage of patients with acromegaly who have normalized IGF-I levels with the use of oral estrogen. To evaluate the percentage of reduction in IGF-I levels with treatment with oral estrogen. To evaluate the safety of using oral estrogen in patients with acromegaly. To evaluate the radiological response analyzed by the magnetic resonance of the turca sella: through the size of the tumor, the volume and the tumor invasion based on the Knosp classification. | — |
Countries
Brazil
Contacts
Public ContactJaqueline Magalhães
Universidade Federal do Rio de Janeiro
Outcome results
None listed