None listed
Conditions
Interventions
Group 1 Type of group
Depot medroxyprogesterone acetate: subcutaneous injection (SC) 104 mg every 3 months
Group name:Group 2 Type of group
Leuprolide acetate: 3.75 mg monthly IM injections.
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:For each sign or symptom (dysmenorrhea, dyspareunia, pelvic pain, pelvic sensitivity or induration) this is defined as an improvement from baseline in the ratings after 6 months of therapy. The symptoms / signs will be evaluated using the Biberoglu and Behrman scale (0-3). Measure:Reduction in the signs and symptoms of endometriosis Timepoints:Month 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:For each sign or symptom (dysmenorrhea, dyspareunia, pelvic pain, pelvic sensitivity or induration) this is defined as an improvement from baseline in the ratings after 6 months of therapy. The symptoms / signs will be evaluated using the Biberoglu and Behrman scale (0-3). Measure:Proportion of women in each treatment group improving from baseline for each symptom / sign at each study visit Timepoints:6 and 12 months ; Outcome name:For each sign or symptom (dysmenorrhea, dyspareunia, pelvic pain, pelvic sensitivity or induration) this is defined as an improvement from baseline in the ratings after 6 months of therapy. The symptoms / signs will be evaluated using the Biberoglu and Behrman scale (0-3). Measure:Difference between treatment groups with respect to change from baseline at each study visit Timepoints:6 months ; Outcome name:For each sign or symptom (dysmenorrhea, dyspareunia, pelvic pain, pelvic sensitivity or induration) this is defined as an improvement from baseline in the ratings after 6 months of therapy. The symptoms / signs will be evaluated using the Biberoglu and Behrman scale (0-3). Measure:Proportion of women in each treatment group improving at least three points in the total score of symptoms and signs Timepoints:3 and 6 months ; Outcome name:For each sign or symptom (dysmenorrhea, dyspareunia, pelvic pain, pelvic sensitivity or induration) this is defined as an improvement from baseline in the ratings after 6 months of therapy. The symptoms / signs will be evaluated using the Biberoglu and Behrman scale (0-3). Measure:The difference between the treatment groups with respect to the change of the baseline until months 3 and 6 and in follow-up visits for the total rating of signs and symptoms Timepoints:3 and 6 months ; Outcome name:Increase of one point in the scales of symptoms of dysmenorrhea, dyspareunia and pelvic pain Measure:The time it takes for symptoms to retu | — |
Outcome results
None listed