Trial · Observational

CompletedPhase not statedResults postedRegistry data

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)

NCTNCT01294371Other idP12-762

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase not stated
Enrollment: 391 participants (actual)
Sponsor: AbbVie (prior sponsor, Abbott) · Industry
Design: Not stated
Countries: 1 country
Russia
Start: Feb 2011
Primary completion: May 2012
Completion: May 2012
First posted: 11 Feb 2011 (estimated)
Last update posted: 22 Jul 2013 (estimated)
Conditions: Genital Endometriosis

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201120122013

Ph –
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
Feb 2011 to May 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Arms1

Other
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment
Time frame · 6 months
Registry description
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.

Secondary outcomes(2)

Percent Compliance to Treatment With Leuprorelin
Time frame · 6 months
Registry description
Compliance to treatment was calculated as the number of leuprorelin doses administered / number of doses prescribed \* 100.
Participants With Estrogen Deficiency Symptoms
Time frame · 6 months
Registry description
Estrogen deficiency symptoms include: * hot flashes, * headaches, * palpitations at rest, * insomnia, * fluctuation of mood.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 6 months

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

Group	Value (percentage of participants)
Leuprorelin	46.5

Secondary and other outcome results(2)

Secondary outcomeMean· 6 months

Percent Compliance to Treatment With Leuprorelin

Group	Value (percent compliance)	Spread
Leuprorelin	96.15	13.81

Secondary outcomeNumber· 6 months

Participants With Estrogen Deficiency Symptoms

Group	Value (participants)
Overall	303
Plus Add-Back Therapy	173
No Add-Back Therapy	130

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
LeuprorelinPatients 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.	–	0 / 390	0 / 390

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 50 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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