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

November 25, 2019 updated by: Evofem Inc.

A Double-Blind Extension Study to Evaluate the Post-Treatment Safety and Duration of Clinical Effect of LIPO-202 in Subjects Who Completed Either the LIPO-202-CL-18 or LIPO-202-CL-19 Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental: 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.
Drug: LIPO-202
PLACEBO_COMPARATOR: Placebo Comparator: 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.
Drug: Placebo
Other Names:
  • Placebo for LIPO-202

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the Post-treatment Duration of Clinical Effect of LIPO-202. Photonumeric Score and Global Abdominal Perception Score.
Time Frame: 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.
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.
Time Frame: 1 Year
Subjects who report an improvement of a least 1-point (grade) on the patient global abdominal perception scale and the photonumeric scale.
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evofem Inc.

Collaborators

Neothetics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ACTUAL)

December 23, 2015

Study Completion (ACTUAL)

February 26, 2016

Study Registration Dates

First Submitted

June 17, 2015

First Submitted That Met QC Criteria

June 26, 2015

First Posted (ESTIMATE)

June 29, 2015

Study Record Updates

Last Update Posted (ACTUAL)

December 10, 2019

Last Update Submitted That Met QC Criteria

November 25, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • LIPO-202-CL-23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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