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)

This study has been completed.
Sponsor:
Collaborator:
Almedis
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01294371
First received: February 10, 2011
Last updated: May 10, 2013
Last verified: May 2013
Results First Received: May 10, 2013  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Genital Endometriosis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Leuprorelin  
STARTED     391  
Treated     390  
COMPLETED     357  
NOT COMPLETED     34  
Adverse Event                 1  
Withdrawal by Subject                 12  
Lost to Follow-up                 6  
Administrative Reason                 1  
Other                 14  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.


Baseline Measures
    Leuprorelin  
Number of Participants  
[units: participants]
  391  
Age  
[units: years]
Mean ± Standard Deviation
  33.8  ± 7.3  
Gender  
[units: participants]
 
Female     391  
Male     0  
Race/Ethnicity, Customized  
[units: participants]
 
White     386  
Asian     5  
Region of Enrollment  
[units: participants]
 
Russian Federation     391  
Endometriosis location [1]
[units: participants]
 
External endometriosis     179  
Internal endometriosis     108  
Combined type     104  
Time from endometriosis diagnosis  
[units: months]
Mean ± Standard Deviation
  3.8  ± 16.7  
Severity of Endometriosis [2]
[units: participants]
 
Minimal     22  
Mild     74  
Moderate     180  
Severe     115  
[1] Endometriosis is divided into genital and extra-genital by location. Genital endometriosis is internal endometriosis - adenomyosis (endometriosis of the uterus). Extra-genital endometriosis is external endometriosis (endometriosis of the uterine cervix, vagina, retro cervix area, ovaries, fallopian tubes, peritoneum, rectouterine space).
[2]

Surgically, endometriosis can be staged I–IV (Revised Classification of the American Society of Reproductive Medicine) per the following:

Stage I (Minimal): Findings restricted to only superficial lesions and possibly a few filmy adhesions;

Stage II (Mild): In addition, some deep lesions are present in the cul-de-sac;

Stage III (Moderate): As above, plus presence of endometriomas on the ovary and more adhesions;

Stage IV (Severe): As above, plus large endometriomas, extensive adhesions.




  Outcome Measures
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1.  Primary:   Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment   [ Time Frame: 6 months ]

2.  Secondary:   Percent Compliance to Treatment With Leuprorelin   [ Time Frame: 6 months ]

3.  Secondary:   Participants With Estrogen Deficiency Symptoms   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: Abbvie (prior sponsor, Abbott)
phone: 800-633-9110


No publications provided


Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01294371     History of Changes
Other Study ID Numbers: P12-762
Study First Received: February 10, 2011
Results First Received: May 10, 2013
Last Updated: May 10, 2013
Health Authority: Russia: Ministry of Health of the Russian Federation