Trial Outcomes & Findings for Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia (NCT NCT00966264)

Results Overview

HRQoL was measured by the 5-Dimensional EuroQol (EQ-5D) questionnaire which measures HRQoL in 5 dimensions of life (scale 0-1)(from very poor=0 to very good=5). The results are the change of HRQoL from baseline at 5 years (EQ-5D score at 5 years - EQ-5D score at baseline)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

236 participants

Primary outcome timeframe

baseline and 5 years

Results posted on

2009-09-02

Participant Flow

Two hundred and thirty-six women referred for essential menorrhagia to five university hospitals in Finland were randomly assigned to treatment with LNG-IUS (n= 119) or hysterectomy (n=117).

All randomised women were analysed as intention-to-treat

Participant milestones

Participant milestones
Measure	LNG-IUS Levonorgestrel releasing intrauterine system (LNG-IUS)	Hysterectomy Hysterectomy (abdominal,laparoscopical or vaginal)
Overall Study STARTED	119	117
Overall Study COMPLETED	115	114
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	LNG-IUS Levonorgestrel releasing intrauterine system (LNG-IUS)	Hysterectomy Hysterectomy (abdominal,laparoscopical or vaginal)
Overall Study Lost to Follow-up	4	3

Baseline Characteristics

Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LNG-IUS n=119 Participants Levonorgestrel releasing intrauterine system (LNG-IUS)	Hysterectomy n=117 Participants Hysterectomy (abdominal,laparoscopical or vaginal)	Total n=236 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	119 Participants n=99 Participants	117 Participants n=107 Participants	236 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age Continuous	43.1 years STANDARD_DEVIATION 3.5 • n=99 Participants	43.0 years STANDARD_DEVIATION 3.2 • n=107 Participants	43 years STANDARD_DEVIATION 3.3 • n=206 Participants
Sex: Female, Male Female	119 Participants n=99 Participants	117 Participants n=107 Participants	236 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants

PRIMARY outcome

Timeframe: baseline and 5 years

Population: The power calculation was made on the basis of an EQ-5D score SD of 19% and alfa=0.05. The study had 80% power to detect a 7.5% difference between the groups

HRQoL was measured by the 5-Dimensional EuroQol (EQ-5D) questionnaire which measures HRQoL in 5 dimensions of life (scale 0-1)(from very poor=0 to very good=5). The results are the change of HRQoL from baseline at 5 years (EQ-5D score at 5 years - EQ-5D score at baseline)

Outcome measures

Outcome measures
Measure	LNG-IUS n=115 Participants Levonorgestrel releasing intrauterine system (LNG-IUS)	Hysterectomy n=114 Participants Hysterectomy (abdominal,laparoscopical or vaginal)
HRQoL (Health Related Quality of Life)	0.08 points on a scale Interval 0.03 to 0.13	0.10 points on a scale Interval 0.05 to 0.15

PRIMARY outcome

Timeframe: baseline, 6 and 12 months, 5 and 10 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 6 and 12 months, 5 and 10 years

Outcome measures

Outcome data not reported

Adverse Events

LNG-IUS

Serious events: 0 serious events

Other events: 80 other events

Deaths: 0 deaths

Hysterectomy

Serious events: 5 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LNG-IUS Levonorgestrel releasing intrauterine system (LNG-IUS)	Hysterectomy Hysterectomy (abdominal,laparoscopical or vaginal)
Surgical and medical procedures bladder perforation	0.00% 0/50	2.8% 3/109 • Number of events 3
Surgical and medical procedures peritonitis	0.00% 0/50	0.92% 1/109 • Number of events 1
Surgical and medical procedures vesicovaginal fistula	0.00% 0/50	0.92% 1/109 • Number of events 1

Other adverse events

Other adverse events
Measure	LNG-IUS Levonorgestrel releasing intrauterine system (LNG-IUS)	Hysterectomy Hysterectomy (abdominal,laparoscopical or vaginal)
Surgical and medical procedures hormonal symptoms	15.1% 18/119 • Number of events 18	0.00% 0/117
Surgical and medical procedures menstrual bleeding problems	51.3% 61/119 • Number of events 61	1.7% 2/117 • Number of events 2
Surgical and medical procedures wund infection	18.0% 9/50 • Number of events 9	18.3% 20/109 • Number of events 20
Surgical and medical procedures perioperative bleeding	2.0% 1/50 • Number of events 1	0.92% 1/109 • Number of events 1
Surgical and medical procedures postoperative bleeding	2.0% 1/50 • Number of events 1	1.8% 2/109 • Number of events 2
Surgical and medical procedures urinary retention	0.84% 1/119 • Number of events 1	3.4% 4/117 • Number of events 4

Additional Information

Ritva Hurskainen

Helsinki University

Phone: +23845872267

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place