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)

NCT01294371 | Completed Results

• 1 other identifier: P12-762
• Study Type: observational
• Target: 391
• Locations: 1 country
• Sites: 28

Brief 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.

Conditions

Genital Endometriosis

Keywords

Lucrin Depot; genital endometriosis; 6 months therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment

  The percentage of participants who received hormone add-back therapy or non-hormone add-back therapy to reduce estrogen deficiency symptom, following local guidelines or therapeutic recommendations, during the 6-month treatment period with leuprorelin.

  6 months

Secondary Outcomes (2)

• Percent Compliance to Treatment With Leuprorelin

  6 months

• Participants With Estrogen Deficiency Symptoms

  6 months

Study Arms (1)

Leuprorelin

Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period. Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• Almedis: collaborator

Study Sites (28)

Site Reference ID/Investigator# 51643

Chelyabinsk, 454092, Russia

Location

Site Reference ID/Investigator# 50577

Irkutsk, 664003, Russia

Location

Site Reference ID/Investigator# 50561

Izhevsk, 426039, Russia

Location

Site Reference ID/Investigator# 50560

Kazan', 420043, Russia

Location

Site Reference ID/Investigator# 50570

Moscow, 101000, Russia

Location

Site Reference ID/Investigator# 50567

Moscow, 117036, Russia

Location

Site Reference ID/Investigator# 50565

Moscow, 117997, Russia

Location

Site Reference ID/Investigator# 50564

Moscow, 121552, Russia

Location

Site Reference ID/Investigator# 62184

Nizhny Novgorod, 603057, Russia

Location

Site Reference ID/Investigator# 50558

Nizhny Novgorod, 603126, Russia

Location

Site Reference ID/Investigator# 50557

Orenburg, 460000, Russia

Location

Site Reference ID/Investigator# 50545

Perm, 614010, Russia

Location

Site Reference ID/Investigator# 53156

Perm, 614066, Russia

Location

Site Reference ID/Investigator# 50547

Saint Petersburg, 190000, Russia

Location

Site Reference ID/Investigator# 50548

Saint Petersburg, 194291, Russia

Location

Site Reference ID/Investigator# 50549

Saint Petersburg, 195257, Russia

Location

Site Reference ID/Investigator# 50551

Saint Petersburg, 196247, Russia

Location

Site Reference ID/Investigator# 50552

Saint Petersburg, 199034, Russia

Location

Site Reference ID/Investigator# 50556

Samara, 443067, Russia

Location

Site Reference ID/Investigator# 50555

Saratov, 410028, Russia

Location

Site Reference ID/Investigator# 50554

Stavropol, 355002, Russia

Location

Site Reference ID/Investigator# 50580

Stavropol, 355030, Russia

Location

Site Reference ID/Investigator# 50579

Tyumen, 625002, Russia

Location

Site Reference ID/Investigator# 50575

Vladivostok, 690600, Russia

Location

Site Reference ID/Investigator# 50562

Volzhskiy, Volgograd Region, 404130, Russia

Location

Site Reference ID/Investigator# 48866

Voronezh, 394000, Russia

Location

Site Reference ID/Investigator# 54502

Voronezh, 394006, Russia

Location

Site Reference ID/Investigator# 50563

Yekaterinburg, 620026, Russia

Location

Related Links

• Related Info

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbvie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Andrey Strugovshchikov, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: February 11, 2011
• Study Start: February 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 22, 2013
• Results First Posted: July 22, 2013

Record last verified: 2013-05

Locations

RU (28)