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

NCT02483533 | Terminated Phase 3 Results

• 1 other identifier: LIPO-202-CL-23
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Central Abdominal Bulging

Outcome Measures

Primary Outcomes (2)

• Evaluation of the Post-treatment Duration of Clinical Effect of LIPO-202. Photonumeric Score and Global Abdominal Perception Score.

  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.

  1 Year

• Evaluation of a 12-month Post-treatment, Non-interventional, Observational Period to Evaluate the Safety and Duration of Clinical Effects of LIPO-202.

  Subjects who report an improvement of a least 1-point (grade) on the patient global abdominal perception scale and the photonumeric scale.

  1 Year

Study Arms (2)

Experimental: LIPO-202

EXPERIMENTAL

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.

Drug: LIPO-202

Placebo Comparator: Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

LIPO-202 DRUG

Experimental: LIPO-202

Placebo DRUG

Also known as: Placebo for LIPO-202

Placebo Comparator: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Evofem Inc.: lead
• Neothetics, Inc: collaborator

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Neothetics

8585501900

Study Officials

• Maria Feldman

  Neothetics, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: June 29, 2015
• Study Start: June 1, 2015
• Primary Completion: December 23, 2015
• Study Completion: February 26, 2016
• Last Updated: December 10, 2019
• Results First Posted: December 10, 2019

Record last verified: 2019-11