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Endometriosis

Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain

Sponsored by Kissei Pharmaceutical Co., Ltd.

About this trial

Last updated 2 years ago

Study ID

19-OBE2109-005

Status

Terminated

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18 to 50 Years
Female
Female

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 4 years ago

What is this trial about?

The primary objective of this extension study is to assess the maintenance of efficacy of linzagolix administered orally once daily for up to an additional 6 months (for up to 12 months of treatment in total) in women who have already completed 6 months of linzagolix treatment at a dose of 75 mg alone or of 200 mg in combination with ABT (E2 1 mg / NETA 0.5 mg), in the management of moderate to severe endometriosis-associated pain (EAP) in women with surgically confirmed endometriosis.

What are the participation requirements?

Yes

Inclusion Criteria

- completed the 6-month treatment in the main study

- agreed to continue to use only the analgesic rescue medication permitted by the protocol during the Treatment and Follow-up Periods

- agreed to continue to comply with the requirements of the study protocol for the duration of the extension study

No

Exclusion Criteria

- is pregnant or breast feeding or is planning a pregnancy within the duration of the of the study (including the Follow-up Period)

- likely to require treatment during the study with any of the restricted medications

- has any other clinically significant gynecologic condition identified during the main study on transvaginal ultrasound (TVUS), on endometrial biopsy or at the manual breast examination, which might interfere with the study efficacy and safety objectives

- meets any of the main study discontinuation criteria

Locations

Location

Status