Trial Outcomes & Findings for Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6) (NCT NCT04335591)
NCT ID: NCT04335591
Last Updated: 2025-04-02
Results Overview
Proportion of subjects with reduction of DYS (Month 3 MCT) and stable or decreased use of analgesics for EAP at Month 12
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
356 participants
Primary outcome timeframe
6-month extension study treatment period (from Month 6 to Month 12)
Results posted on
2025-04-02
Participant Flow
Overall, 356 subjects entered the extension study and were treated. With the exception of 3 subjects who met a discontinuation criterion at Month 6, all other subjects who entered the extension study were included in the TEAS. The PP EAS consisted of 336 subjects. All 356 subjects who entered the extension study were included in the ESAF.
Subjects who received placebo in the main study were randomized in a 1:1 ratio to either linzagolix (=LGX) 75 mg alone (with Add-back (=ABT) placebo) or LGX 200 mg with ABT, as per the main study randomization schedule. Subjects who received active treatment continued with the same treatment (LGX 75 mg alone or LGX 200 mg with ABT).
Participant milestones
| Measure |
LGX 75 mg
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x LGX 75 mg tab.
* 1 x LGX 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6 months\]
* 1 x LGX 75 mg tab.
* 1 x LGX 200 mg placebo tab.
* 1 x ABT placebo cap.
|
LGX 200 mg+ABT
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x LGX 200 mg tab.
* 1 x LGX 75 mg placebo tab.
* 1 x ABT cap. (E2 1 mg / NETA 0.5 mg)
\[Extension study: 6 months\]
* 1 x LGX 200 mg tab.
* 1 x LGX 75 mg placebo tab.
* 1 x ABT cap. (E2 1 mg / NETA 0.5 mg)
|
Placebo / LGX 75 mg
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x LGX 75 mg placebo tab.
* 1 x LGX 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6months\]
* 1 x LGX 75 mg tab.
* 1 x LGX 200 mg placebo tab.
* 1 x ABT placebo cap.
|
Placebo / LGX 200 mg+ABT
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x LGX 75 mg placebo tab.
* 1 x LGX 200 mg placebo tab.
* 1 x ABT placebo cap
\[Extension study: 6 months\]
* 1 x LGX 200 mg tab.
* 1 x LGX 75 mg placebo tab.
* 1 x ABT cap. (E2 1 mg / NETA 0.5 mg)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
119
|
122
|
58
|
57
|
|
Overall Study
COMPLETED
|
101
|
110
|
49
|
50
|
|
Overall Study
NOT COMPLETED
|
18
|
12
|
9
|
7
|
Reasons for withdrawal
| Measure |
LGX 75 mg
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x LGX 75 mg tab.
* 1 x LGX 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6 months\]
* 1 x LGX 75 mg tab.
* 1 x LGX 200 mg placebo tab.
* 1 x ABT placebo cap.
|
LGX 200 mg+ABT
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x LGX 200 mg tab.
* 1 x LGX 75 mg placebo tab.
* 1 x ABT cap. (E2 1 mg / NETA 0.5 mg)
\[Extension study: 6 months\]
* 1 x LGX 200 mg tab.
* 1 x LGX 75 mg placebo tab.
* 1 x ABT cap. (E2 1 mg / NETA 0.5 mg)
|
Placebo / LGX 75 mg
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x LGX 75 mg placebo tab.
* 1 x LGX 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6months\]
* 1 x LGX 75 mg tab.
* 1 x LGX 200 mg placebo tab.
* 1 x ABT placebo cap.
|
Placebo / LGX 200 mg+ABT
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x LGX 75 mg placebo tab.
* 1 x LGX 200 mg placebo tab.
* 1 x ABT placebo cap
\[Extension study: 6 months\]
* 1 x LGX 200 mg tab.
* 1 x LGX 75 mg placebo tab.
* 1 x ABT cap. (E2 1 mg / NETA 0.5 mg)
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
2
|
3
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
8
|
4
|
4
|
5
|
|
Overall Study
Subject planning pregnancy
|
0
|
1
|
0
|
0
|
|
Overall Study
Ukrainian Russian war conflict
|
4
|
5
|
2
|
0
|
Baseline Characteristics
Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6)
Baseline characteristics by cohort
| Measure |
LGX 75 mg
n=119 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6 months\] Same treatment as the main study
|
LGX 200 mg+ABT
n=122 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 200 mg tab.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x ABT cap. (E2 1 mg / NETA 0.5 mg)
\[Extension study: 6 months\] Same treatment as the main study
|
Placebo/LGX 75 mg
n=58 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6months\] Same treatment as LGX 75 mg group in the extension study
|
Placebo/LGX 200 mg+ABT
n=57 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap
\[Extension study: 6 months\] Same treatment as LGX 200 mg+ABT group in the extension study
|
Total
n=356 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
119 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
356 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
35.1 Years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
34.8 Years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
34.3 Years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
35.0 Years
STANDARD_DEVIATION 7.7 • n=4 Participants
|
34.8 Years
STANDARD_DEVIATION 6.8 • n=21 Participants
|
|
Age, Customized
|
35.0 Years
n=5 Participants
|
35.0 Years
n=7 Participants
|
34.5 Years
n=5 Participants
|
36.0 Years
n=4 Participants
|
35.0 Years
n=21 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
356 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
117 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
348 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
117 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
351 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Austria
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Region of Enrollment
Romania
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=4 Participants
|
20 participants
n=21 Participants
|
|
Region of Enrollment
Czechia
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Region of Enrollment
Ukraine
|
59 participants
n=5 Participants
|
50 participants
n=7 Participants
|
30 participants
n=5 Participants
|
24 participants
n=4 Participants
|
163 participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
46 participants
n=5 Participants
|
51 participants
n=7 Participants
|
21 participants
n=5 Participants
|
27 participants
n=4 Participants
|
145 participants
n=21 Participants
|
|
Region of Enrollment
Bulgaria
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
8 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
16 participants
n=21 Participants
|
|
Weight
|
68.475 kg
STANDARD_DEVIATION 15.115 • n=5 Participants
|
65.210 kg
STANDARD_DEVIATION 13.497 • n=7 Participants
|
64.004 kg
STANDARD_DEVIATION 11.103 • n=5 Participants
|
68.029 kg
STANDARD_DEVIATION 13.826 • n=4 Participants
|
66.560 kg
STANDARD_DEVIATION 13.830 • n=21 Participants
|
|
BMI
|
24.79 kg/m2
STANDARD_DEVIATION 5.54 • n=5 Participants
|
23.81 kg/m2
STANDARD_DEVIATION 4.58 • n=7 Participants
|
23.39 kg/m2
STANDARD_DEVIATION 4.01 • n=5 Participants
|
24.77 kg/m2
STANDARD_DEVIATION 5.06 • n=4 Participants
|
24.22 kg/m2
STANDARD_DEVIATION 4.93 • n=21 Participants
|
PRIMARY outcome
Timeframe: 6-month extension study treatment period (from Month 6 to Month 12)Proportion of subjects with reduction of DYS (Month 3 MCT) and stable or decreased use of analgesics for EAP at Month 12
Outcome measures
| Measure |
LGX 75 mg
n=111 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6 months\] Same treatment as the main study
|
LGX 200 mg+ABT
n=111 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 200 mg tab.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x ABT cap. (E2 1 mg / NETA 0.5 mg)
\[Extension study: 6 months\] Same treatment as the main study
|
Placebo/LGX 75 mg
n=57 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6months\] Same treatment as LGX 75 mg group in the extension study
|
Placebo/LGX 200 mg+ABT
n=55 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap
\[Extension study: 6 months\] Same treatment as LGX 200 mg+ABT group in the extension study
|
|---|---|---|---|---|
|
Dysmenorrhea
|
62 Participants
|
101 Participants
|
32 Participants
|
43 Participants
|
PRIMARY outcome
Timeframe: 6-month extension study treatment period (from Month 6 to Month 12)Proportion of subjects with reduction of NMPP (Month 3 MCT) and stable or decreased use of analgesics for EAP at Month 12
Outcome measures
| Measure |
LGX 75 mg
n=111 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6 months\] Same treatment as the main study
|
LGX 200 mg+ABT
n=111 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 200 mg tab.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x ABT cap. (E2 1 mg / NETA 0.5 mg)
\[Extension study: 6 months\] Same treatment as the main study
|
Placebo/LGX 75 mg
n=57 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6months\] Same treatment as LGX 75 mg group in the extension study
|
Placebo/LGX 200 mg+ABT
n=55 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap
\[Extension study: 6 months\] Same treatment as LGX 200 mg+ABT group in the extension study
|
|---|---|---|---|---|
|
Non-menstrual Pelvic Pain
|
66 Participants
|
75 Participants
|
34 Participants
|
27 Participants
|
Adverse Events
LGX 75 mg
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
LGX 200 mg+ABT
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo/LGX 75 mg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo/LGX 200 mg+ABT
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LGX 75 mg
n=119 participants at risk
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6 months\] Same treatment as the main study
|
LGX 200 mg+ABT
n=122 participants at risk
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 200 mg tab.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x ABT cap. (E2 1 mg / NETA 0.5 mg)
\[Extension study: 6 months\] Same treatment as the main study
|
Placebo/LGX 75 mg
n=58 participants at risk
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6months\] Same treatment as LGX 75 mg group in the extension study
|
Placebo/LGX 200 mg+ABT
n=57 participants at risk
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap
\[Extension study: 6 months\] Same treatment as LGX 200 mg+ABT group in the extension study
|
|---|---|---|---|---|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.00%
0/119 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/122 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/58 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
1.8%
1/57 • Number of events 1 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.84%
1/119 • Number of events 1 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/122 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/58 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/57 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.84%
1/119 • Number of events 1 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/122 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/58 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/57 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Psychiatric disorders
Anxiety
|
0.84%
1/119 • Number of events 1 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/122 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/58 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/57 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
Other adverse events
| Measure |
LGX 75 mg
n=119 participants at risk
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6 months\] Same treatment as the main study
|
LGX 200 mg+ABT
n=122 participants at risk
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 200 mg tab.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x ABT cap. (E2 1 mg / NETA 0.5 mg)
\[Extension study: 6 months\] Same treatment as the main study
|
Placebo/LGX 75 mg
n=58 participants at risk
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6months\] Same treatment as LGX 75 mg group in the extension study
|
Placebo/LGX 200 mg+ABT
n=57 participants at risk
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap
\[Extension study: 6 months\] Same treatment as LGX 200 mg+ABT group in the extension study
|
|---|---|---|---|---|
|
Vascular disorders
Hot flush
|
3.4%
4/119 • Number of events 4 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
4.1%
5/122 • Number of events 5 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
6.9%
4/58 • Number of events 4 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/57 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Nervous system disorders
Headache
|
4.2%
5/119 • Number of events 5 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
2.5%
3/122 • Number of events 3 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
5.2%
3/58 • Number of events 6 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
5.3%
3/57 • Number of events 4 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
7/119 • Number of events 7 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/122 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
5.2%
3/58 • Number of events 4 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
3.5%
2/57 • Number of events 4 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
2.5%
3/119 • Number of events 4 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
2.5%
3/122 • Number of events 5 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
1.7%
1/58 • Number of events 1 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
5.3%
3/57 • Number of events 7 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Infections and infestations
COVID-19
|
5.0%
6/119 • Number of events 6 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
4.9%
6/122 • Number of events 6 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
1.7%
1/58 • Number of events 1 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
3.5%
2/57 • Number of events 2 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.84%
1/119 • Number of events 1 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
1.6%
2/122 • Number of events 2 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
5.2%
3/58 • Number of events 3 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
5.3%
3/57 • Number of events 3 • 6-month extension study treatment period (from Month 6 to Month 12)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavorable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
Additional Information
Clinical Development Division
Kissei Pharmaceutical Co., Ltd
Phone: Email only
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place