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

Phase 3

Terminated

• Conditions: Central Abdominal Bulging
• Interventions: Drug: Placebo; Drug: LIPO-202

• Registration Number: NCT02483533
• Lead Sponsor: Evofem Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-17
• Study First Submitted QC: 2015-06-26
• Study First Posted: 2015-06-29
• Primary Completion: 2015-12-23
• Study Completion: 2016-02-26
• Results First Submitted: 2018-10-30
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-25
• Last Update Submitted: 2019-11-25
• Results First Posted: 2019-12-10
• Last Update Posted: 2019-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator: Placebo	Placebo	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.
Experimental: LIPO-202	LIPO-202	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.

Primary Outcome Measures

Name	Time	Method
Evaluation of a 12-month Post-treatment, Non-interventional, Observational Period to Evaluate the Safety and Duration of Clinical Effects of LIPO-202.	1 Year	Subjects who report an improvement of a least 1-point (grade) on the patient global abdominal perception scale and the photonumeric scale.
Evaluation of the Post-treatment Duration of Clinical Effect of LIPO-202. Photonumeric Score and Global Abdominal Perception Score.	1 Year	Measured by change in clinician reported photonumeric score and change in patient reported global abdominal perception score. Patient-rated changes in amount of bulging or flatness of their belly using the 5-point scale provided as pictures where zero is flat and five is big bulge.