Extension Study to Evaluate the Post-Treatment Safety and Duration of Clinical Effect of LIPO-202

Evofem

Status and phase: Terminated; Phase 3

Conditions: Central Abdominal Bulging

Treatments: Drug: LIPO-202; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02483533

LIPO-202-CL-23

Details and patient eligibility

About

LIPO-202-CL-23 is a follow-on study to evaluate the post-treatment safety and duration of clinical effect of LIPO-202 in subjects that completed either the LIPO-202-CL-18 (NCT02397499) or LIPO-202-CL-19 (NCT02398188). No risks related to treatment are anticipated as subjects will not receive additional treatment with LIPO-202 or Placebo for LIPO-202 in this follow-on study.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy male or non-pregnant female subjects who completed Study LIPO-202-CL-18 or LIPO-202-CL-19
• Capable of providing written consent
• Willing to comply with the study procedures and schedule

Exclusion criteria

• Female subjects who are pregnant or are not using adequate birth control methods
• Plan on starting a weight loss or exercise program during the study
• Plan to enroll in another investigational drug or device study
• Unlikely or unable to adhere to the study visit schedule

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Experimental: LIPO-202

Experimental group

Description:

Subjects received either LIPO-202 or Placebo for LIPO-202 in the parent study (LIPO-202-CL-18 or LIPO-202-CL-19). Subjects will not receive any additional treatment in this follow-on study.

Treatment:

Drug: LIPO-202

Placebo Comparator: Placebo

Placebo Comparator group

Description:

Subjects received either LIPO-202 or Placebo for LIPO-202 in the parent study (LIPO-202-CL-18 or LIPO-202-CL-19). Subjects will not receive any additional treatment in this follow-on study.

Treatment:

Drug: Placebo