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

NCT ID: NCT02483533

Last Updated: 2019-12-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-02-26

Brief Summary

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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

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Conditions

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Central Abdominal Bulging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

LIPO-202

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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LIPO-202

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Placebo for LIPO-202

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neothetics, Inc

INDUSTRY

Sponsor Role collaborator

Evofem Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Feldman

Role: STUDY_DIRECTOR

Neothetics, Inc

Other Identifiers

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LIPO-202-CL-23

Identifier Type: -

Identifier Source: org_study_id