Subcutaneous injections of depot medroxyprogesterone acetate versus Leuprolide acetate for the reduction of pain associated with endometriosis in European and Asian women. A Phase III, randomized, parallel group, multinational, multicenter study including evaluations of bone mineral density and substudies of coagulation and lipid profiles.

Not Applicable

• Conditions: -N80; N80

• Registration Number: PER-025-01
• Lead Sponsor: PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-05-30
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Pre-menopausal women aged 18-49 years willing to use a non-hormonal barrier contraceptive method for 18 months, during the 6 months of the treatment period and 12 months of follow-up.
• Patients can have:
o Endometriosis of recent diagnosis confirmed by laparoscopy without any surgical treatment, OR
o Symptoms of persistent or recurrent endometriosis during at least 3 months of duration (and after discontinuation of initial therapy) and endometriosis confirmed by laparoscopy within the last 24 months prior to entering the study. For patients in this category, cultures and updated pelvic sonography tests should be performed to exclude sexually transmitted diseases or other diagnoses as an alternative cause for pelvic pain.
• Symptomatic subjects, with or without infertility, and a Total Pelvic Score of at least 6 or more in the following 5 signs / symptoms of endometriosis (including a score of 2 or more in each category 1, 2 and 3 of pain) .
• Pap smear documented as normal and normal mammography (women> 35 years) within 12 months prior to inclusion.
• Willing to sign the informed consent.
• Arranged and able to comply with the specific procedures of the study.

Exclusion Criteria

• Pregnant or breastfeeding.
• Known breast cancer or mammography results of suspected malignancies or require a follow-up of 6 months. Note: mammograms (within the last 12 months) are only required for women who are> 35 years old.
• Use of hormonal agents including: oral contraceptives, Danazol and agonists HLGn for 3 months, AMPD-IM for 12 months prior to inclusion in this study
• DM0 below the acceptable criteria during filtering: lumbar or femur column,
• T rating <-1.0, or history of pathological fracture and / or compression.
• Abnormal cervical cytology (PAP required within the last 12 months): CGAND, LIEBG, or LIEAG. however, CEAND (atypical squamous cells of undetermined importance) is allowed in this study.
• Active disease or history of liver or kidney disease:
• Liver disease defined as having aspartate aminotransferase (AST / SGOT) or alanine aminotransferase (ALT / SGPT) or elevated total bilirubin by 2.5 times the upper normal limit.
• Kidney disease defined as having creatinine greater than 1.8 mg / dL.
• History of severe hypersensitivity reactions or signs of severe virilization due to an endocrine disorder, hormonal therapy or Danazol therapy.
• Well-documented history of thromboembolic events: cerebrovascular accident or venous thromboembolism (deep vein thrombosis or pulmonary embolus), 1 a history of superficial thrombophlebitis is not exclusive).
• An a-coagulant therapy or any other drug, for example steroids (prednisone or any other derivative of cortisone) in the past 6 months, in doses that could suppress the hypothalamic-pituitary adrenal axis.
• uncontrolled hypertension confirmed present: Defined as systolic> 180mmHg or diastolic> 110mmHg.
• Insulin-dependent diabetes mellitus (IDDM) or noninsulin-dependent diabetes mellitus (NIDDM) that is poorly controlled.
• Undiagnosed abnormal genital bleeding.
• Concomitant use of other investigational drugs.
• Any condition (eg, serious medical illness, psychiatric disturbances, alcoholism) that could cause a subject not to be able to strictly comply with the study instructions.
• Any subject taking aminoglutethimide.

Study & Design

• Study Type: Interventional
• Study Design: Not specified