Trial Outcomes & Findings for 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) (NCT NCT01294371)

Last Updated: 2013-07-22

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

391 participants

Primary outcome timeframe

6 months

Results posted on

2013-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	391
Overall Study Treated	390
Overall Study COMPLETED	357
Overall Study NOT COMPLETED	34

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	12
Overall Study Lost to Follow-up	6
Overall Study Administrative Reason	1
Overall Study Other	14

Baseline Characteristics

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)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Leuprorelin n=391 Participants 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.
Age Continuous	33.8 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	391 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized White	386 participants n=5 Participants
Race/Ethnicity, Customized Asian	5 participants n=5 Participants
Region of Enrollment Russian Federation	391 participants n=5 Participants
Endometriosis location External endometriosis	179 participants n=5 Participants
Endometriosis location Internal endometriosis	108 participants n=5 Participants
Endometriosis location Combined type	104 participants n=5 Participants
Time from endometriosis diagnosis	3.8 months STANDARD_DEVIATION 16.7 • n=5 Participants
Severity of Endometriosis Minimal	22 participants n=5 Participants
Severity of Endometriosis Mild	74 participants n=5 Participants
Severity of Endometriosis Moderate	180 participants n=5 Participants
Severity of Endometriosis Severe	115 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Full Analysis Set included all all patients who had signed the personal authorization form and who administered at least one dose of leuprorelin and who had attended at least one post-baseline visit.

Outcome measures

Outcome measures
Measure	Leuprorelin n=387 Participants 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.	Plus Add-Back Therapy Participants with genital endometriosis received leuprorelin in accordance with the respective Marketing Authorization/ Manufacturer's directions, and add-back therapy following local guidelines or therapeutic recommendations.	No Add-Back Therapy Participants with genital endometriosis received leuprorelin in accordance with the respective Marketing Authorization/ Manufacturer's directions, and no add-back therapy.
Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment Any Add-back Therapy Usage	46.5 percentage of participants	—	—
Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment Any Hormonal Add-back Therapy Usage	21.7 percentage of participants	—	—
Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment Any Non-hormonal Add-back Therapy Usage	26.9 percentage of participants	—	—

SECONDARY outcome

Timeframe: 6 months

Population: Participants who received at least one dose of leuprorelin.

Compliance to treatment was calculated as the number of leuprorelin doses administered / number of doses prescribed \* 100.

Outcome measures

Outcome measures
Measure	Leuprorelin n=390 Participants 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.	Plus Add-Back Therapy Participants with genital endometriosis received leuprorelin in accordance with the respective Marketing Authorization/ Manufacturer's directions, and add-back therapy following local guidelines or therapeutic recommendations.	No Add-Back Therapy Participants with genital endometriosis received leuprorelin in accordance with the respective Marketing Authorization/ Manufacturer's directions, and no add-back therapy.
Percent Compliance to Treatment With Leuprorelin	96.15 percent compliance Standard Deviation 13.81	—	—

SECONDARY outcome

Timeframe: 6 months

Population: Full Analysis Set

Estrogen deficiency symptoms include: * hot flashes, * headaches, * palpitations at rest, * insomnia, * fluctuation of mood.

Outcome measures

Outcome measures
Measure	Leuprorelin n=387 Participants 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.	Plus Add-Back Therapy n=178 Participants Participants with genital endometriosis received leuprorelin in accordance with the respective Marketing Authorization/ Manufacturer's directions, and add-back therapy following local guidelines or therapeutic recommendations.	No Add-Back Therapy n=209 Participants Participants with genital endometriosis received leuprorelin in accordance with the respective Marketing Authorization/ Manufacturer's directions, and no add-back therapy.
Participants With Estrogen Deficiency Symptoms Hot Flashes	303 participants	173 participants	130 participants
Participants With Estrogen Deficiency Symptoms Headaches	139 participants	94 participants	45 participants
Participants With Estrogen Deficiency Symptoms Palpitations at Rest	100 participants	73 participants	27 participants
Participants With Estrogen Deficiency Symptoms Overall Insomnia	190 participants	116 participants	74 participants
Participants With Estrogen Deficiency Symptoms Fluctuation of Mood	203 participants	113 participants	90 participants

Adverse Events

Leuprorelin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Global Medical Services

Abbvie (prior sponsor, Abbott)

Phone: 800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER