N/A
Completed N=391
Observational Program to Assess Routine Use of Add-back Therapy in Patients With Endometriosis in Russian Federation, Planned for 6-month Course of Lucrin Depot® (Leuprorelin)
Genital Endometriosis
Source: ClinicalTrials.gov NCT01294371 ↗
Enrolled (actual)
391
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcomePrimary: Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment — 46.5; 21.7; 26.9 percentage of participants
Summary
The purpose of this study is to assess rates of administration of add-back therapy in patients with endometriosis in the Russian Federation, during a 6-month course of gonadoliberin agonist leuprorelin 3.75 mg.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment |
46.5; 21.7; 26.9 | — |
| SECONDARY Percent Compliance to Treatment With Leuprorelin |
96.15 | — |
| SECONDARY Participants With Estrogen Deficiency Symptoms |
303; 173; 130; 139; 94; 45 | — |
Eligibility Criteria
Inclusion Criteria
- Age from 18 to 50 years
- Written Patient Consent for Use/Disclosure of Data
- Diagnosis of genital endometriosis confirmed by laparoscopy (external genital endometriosis) or ultrasound (internal genital endometriosis)
- Candidate for treatment with Lucrin Depot for 6-month course
- Patients with suspected endometriosis suffering from chronic pelvic pain if other reasons for pain are excluded
Exclusion Criteria
- Contraindications to administration of Lucrin Depot (leuprorelin):
- Hypersensitivity to leuprorelin similar products of protein origin or any of the excipients in drug product composition
- Vaginal bleedings of unknown etiology
- Hysterectomy
- Pregnancy and lactation
- Menopause (absence of cyclic menstrual hemorrhages for 1 year before the start of this program)
- Acute infectious period, inclusive of acute inflammatory diseases of small pelvic organs
- Other contraindications that make the patients participation impossible (by investigator judgment)
- Previous enrollment in the present program
- Extra-genital endometriosis
Data sourced from ClinicalTrials.gov (NCT01294371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.