Trial Outcomes & Findings for Evaluation of Modified Treatment Regimens for Treatment of Heavy Menstrual Bleeding Using the HerOption® System (NCT NCT00094536)
NCT ID: NCT00094536
Last Updated: 2017-03-03
Results Overview
Success is defined as a pictorial bleeding assessment chart (PBAC) score of ≤ 75 at 1-year post-treatment; a score which corresponds to normal menstruation levels.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
82 participants
Primary outcome timeframe
1 Year
Results posted on
2017-03-03
Participant Flow
Enrollment commenced 8/13/04, and was completed 1/20/06, with final 3-year follow-up occurring on 3/17/09. Assessments occurred at gynecologic offices. The majority of procedures occurred in the office setting, and the remainder in the ASC setting.
Subjects were consented and assessed for inclusion/exclusion; qualified subjects underwent treatment and are considered the intent-to-treat group. Sample size was targeted for 76 subjects, however FDA granted the request for additional subjects to undergo treatment if consented at the time of completion of enrollment.
Participant milestones
| Measure |
Extended Treatment Regimen
Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
|
|---|---|
|
Inclusion Exclusion Evaluation
STARTED
|
106
|
|
Inclusion Exclusion Evaluation
COMPLETED
|
82
|
|
Inclusion Exclusion Evaluation
NOT COMPLETED
|
24
|
|
Treatment and Follow-up
STARTED
|
82
|
|
Treatment and Follow-up
12 Month Follow-up
|
69
|
|
Treatment and Follow-up
24 Month Follow-up
|
53
|
|
Treatment and Follow-up
36 Month Follow-up
|
51
|
|
Treatment and Follow-up
COMPLETED
|
51
|
|
Treatment and Follow-up
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
Extended Treatment Regimen
Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
|
|---|---|
|
Inclusion Exclusion Evaluation
Did not qualify for study treatment
|
24
|
|
Treatment and Follow-up
Adverse Event
|
4
|
|
Treatment and Follow-up
Lack of Efficacy
|
9
|
|
Treatment and Follow-up
Lost to Follow-up
|
7
|
|
Treatment and Follow-up
Withdrawal by Subject
|
1
|
|
Treatment and Follow-up
Subject non-compliance
|
9
|
|
Treatment and Follow-up
Unable to attend visits
|
1
|
Baseline Characteristics
Evaluation of Modified Treatment Regimens for Treatment of Heavy Menstrual Bleeding Using the HerOption® System
Baseline characteristics by cohort
| Measure |
Extended Treatment Regimen
n=106 Participants
Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
106 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
97 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
16 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
79 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
9 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
106 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 YearPopulation: Intention-to-Treat Analysis
Success is defined as a pictorial bleeding assessment chart (PBAC) score of ≤ 75 at 1-year post-treatment; a score which corresponds to normal menstruation levels.
Outcome measures
| Measure |
Extended Treatment Regimen
n=82 Participants
Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
|
|---|---|
|
Success (Reduction in Menstruation to Normal Levels)
|
59 Participants
|
Adverse Events
Extended Treatment Regimen
Serious events: 19 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Extended Treatment Regimen
n=82 participants at risk
Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
|
|---|---|
|
Reproductive system and breast disorders
Adnexial mass/cyst
|
1.2%
1/82 • Number of events 1 • Adverse events were both passively and actively collected and assessed throughout the study, up to 3-years post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Bicep Tendon Surgery
|
1.2%
1/82 • Number of events 1 • Adverse events were both passively and actively collected and assessed throughout the study, up to 3-years post-treatment.
|
|
Reproductive system and breast disorders
Cancer - Breast
|
1.2%
1/82 • Number of events 1 • Adverse events were both passively and actively collected and assessed throughout the study, up to 3-years post-treatment.
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
1.2%
1/82 • Number of events 1 • Adverse events were both passively and actively collected and assessed throughout the study, up to 3-years post-treatment.
|
|
Reproductive system and breast disorders
Endometriosis
|
1.2%
1/82 • Number of events 1 • Adverse events were both passively and actively collected and assessed throughout the study, up to 3-years post-treatment.
|
|
Surgical and medical procedures
Failed Steriliztion Device Placement
|
1.2%
1/82 • Number of events 1 • Adverse events were both passively and actively collected and assessed throughout the study, up to 3-years post-treatment.
|
|
Reproductive system and breast disorders
Hematometria
|
1.2%
1/82 • Number of events 1 • Adverse events were both passively and actively collected and assessed throughout the study, up to 3-years post-treatment.
|
|
Surgical and medical procedures
Labial Hypertrophy Surgery
|
1.2%
1/82 • Number of events 1 • Adverse events were both passively and actively collected and assessed throughout the study, up to 3-years post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Fusion Surgery
|
1.2%
1/82 • Number of events 1 • Adverse events were both passively and actively collected and assessed throughout the study, up to 3-years post-treatment.
|
|
Reproductive system and breast disorders
Menorrhagia/Lack of Efficacy
|
7.3%
6/82 • Number of events 6 • Adverse events were both passively and actively collected and assessed throughout the study, up to 3-years post-treatment.
|
|
Reproductive system and breast disorders
Polycystic Ovarian Syndrome
|
1.2%
1/82 • Number of events 2 • Adverse events were both passively and actively collected and assessed throughout the study, up to 3-years post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Shoulder Slap Lesion Surgery
|
1.2%
1/82 • Number of events 1 • Adverse events were both passively and actively collected and assessed throughout the study, up to 3-years post-treatment.
|
|
Renal and urinary disorders
Urinary Incontinence Surgery
|
1.2%
1/82 • Number of events 1 • Adverse events were both passively and actively collected and assessed throughout the study, up to 3-years post-treatment.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
1.2%
1/82 • Number of events 1 • Adverse events were both passively and actively collected and assessed throughout the study, up to 3-years post-treatment.
|
|
Surgical and medical procedures
Uterine Perforation During Sterilization Procedure
|
1.2%
1/82 • Number of events 1 • Adverse events were both passively and actively collected and assessed throughout the study, up to 3-years post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Umbilical Hernia Surgery
|
1.2%
1/82 • Number of events 1 • Adverse events were both passively and actively collected and assessed throughout the study, up to 3-years post-treatment.
|
Other adverse events
| Measure |
Extended Treatment Regimen
n=82 participants at risk
Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
|
|---|---|
|
Reproductive system and breast disorders
Pain/Discomfort - Pelvic
|
6.1%
5/82 • Number of events 5 • Adverse events were both passively and actively collected and assessed throughout the study, up to 3-years post-treatment.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
4.9%
4/82 • Number of events 4 • Adverse events were both passively and actively collected and assessed throughout the study, up to 3-years post-treatment.
|
|
Reproductive system and breast disorders
Vaginal Infection
|
4.9%
4/82 • Number of events 4 • Adverse events were both passively and actively collected and assessed throughout the study, up to 3-years post-treatment.
|
|
Reproductive system and breast disorders
Endometritis
|
3.7%
3/82 • Number of events 3 • Adverse events were both passively and actively collected and assessed throughout the study, up to 3-years post-treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place