Genital Endometriosis
Conditions
Keywords
Lucrin Depot, genital endometriosis, 6 months therapy
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.
Detailed description
This was a non-interventional, observational program in which Lucrin Depot (leuprorelin acetate) and add-back therapy (hormone and non-hormone) were prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication (for leuprorelin acetate) and with regards to the local guidelines or therapeutic recommendation (for add-back therapy). The rationale for the study was the necessity to characterize the patient population and long-term leuprorelin acetate administration in the Russian Federation. Further, it was important to characterize the compliance, tolerability, and safety profile of this therapy in the routine clinical care setting in the Russian Federation.
Interventions
None listed
Sponsors
Almedis
AbbVie (prior sponsor, Abbott)
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment | 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Percent Compliance to Treatment With Leuprorelin | 6 months | Compliance to treatment was calculated as the number of leuprorelin doses administered / number of doses prescribed \* 100. |
| Participants With Estrogen Deficiency Symptoms | 6 months | Estrogen deficiency symptoms include: * hot flashes, * headaches, * palpitations at rest, * insomnia, * fluctuation of mood. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 391 |
| Total | 391 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative Reason | 1 |
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Other | 14 |
| Overall Study | Withdrawal by Subject | 12 |
Baseline characteristics
| Characteristic | Leuprorelin |
|---|---|
| Age Continuous | 33.8 years STANDARD_DEVIATION 7.3 |
| Endometriosis location Combined type | 104 participants |
| Endometriosis location External endometriosis | 179 participants |
| Endometriosis location Internal endometriosis | 108 participants |
| Race/Ethnicity, Customized Asian | 5 participants |
| Race/Ethnicity, Customized White | 386 participants |
| Region of Enrollment Russian Federation | 391 participants |
| Severity of Endometriosis Mild | 74 participants |
| Severity of Endometriosis Minimal | 22 participants |
| Severity of Endometriosis Moderate | 180 participants |
| Severity of Endometriosis Severe | 115 participants |
| Sex: Female, Male Female | 391 Participants |
| Sex: Female, Male Male | 0 Participants |
| Time from endometriosis diagnosis | 3.8 months STANDARD_DEVIATION 16.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 390 |
| serious Total, serious adverse events | 0 / 390 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Leuprorelin | 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 |
| Leuprorelin | 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 |
| Leuprorelin | 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
Participants With Estrogen Deficiency Symptoms
Estrogen deficiency symptoms include: * hot flashes, * headaches, * palpitations at rest, * insomnia, * fluctuation of mood.
Time frame: 6 months
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Leuprorelin | Participants With Estrogen Deficiency Symptoms | Overall Insomnia | 190 participants |
| Leuprorelin | Participants With Estrogen Deficiency Symptoms | Palpitations at Rest | 100 participants |
| Leuprorelin | Participants With Estrogen Deficiency Symptoms | Hot Flashes | 303 participants |
| Leuprorelin | Participants With Estrogen Deficiency Symptoms | Headaches | 139 participants |
| Leuprorelin | Participants With Estrogen Deficiency Symptoms | Fluctuation of Mood | 203 participants |
| Plus Add-Back Therapy | Participants With Estrogen Deficiency Symptoms | Palpitations at Rest | 73 participants |
| Plus Add-Back Therapy | Participants With Estrogen Deficiency Symptoms | Hot Flashes | 173 participants |
| Plus Add-Back Therapy | Participants With Estrogen Deficiency Symptoms | Headaches | 94 participants |
| Plus Add-Back Therapy | Participants With Estrogen Deficiency Symptoms | Overall Insomnia | 116 participants |
| Plus Add-Back Therapy | Participants With Estrogen Deficiency Symptoms | Fluctuation of Mood | 113 participants |
| No Add-Back Therapy | Participants With Estrogen Deficiency Symptoms | Fluctuation of Mood | 90 participants |
| No Add-Back Therapy | Participants With Estrogen Deficiency Symptoms | Overall Insomnia | 74 participants |
| No Add-Back Therapy | Participants With Estrogen Deficiency Symptoms | Hot Flashes | 130 participants |
| No Add-Back Therapy | Participants With Estrogen Deficiency Symptoms | Palpitations at Rest | 27 participants |
| No Add-Back Therapy | Participants With Estrogen Deficiency Symptoms | Headaches | 45 participants |
Secondary
Percent Compliance to Treatment With Leuprorelin
Compliance to treatment was calculated as the number of leuprorelin doses administered / number of doses prescribed \* 100.
Time frame: 6 months
Population: Participants who received at least one dose of leuprorelin.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Leuprorelin | Percent Compliance to Treatment With Leuprorelin | 96.15 percent compliance | Standard Deviation 13.81 |