Trial · NCT00966264

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

NCT00966264, Phase 3, Completed, University of Helsinki; results first posted 2009-08-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia. Trials, record NCT00966264. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00966264

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia
NCT number: NCT00966264
Status: Completed
Phases: Phase 3
Enrollment: 236 participants, actual
Lead sponsor: University of Helsinki
Conditions: Menorrhagia
Interventions: LNG-IUS, Hysterectomy
First posted: 2009-08-26
Last updated: 2009-09-02
Results first posted: 2009-08-26

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	HRQoL (Health Related Quality of Life)	baseline and 5 years	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)
Primary	Costs	baseline, 6 and 12 months, 5 and 10 years
Secondary	Depression	baseline, 6 and 12 months, 5 and 10 years

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	HRQoL (Health Related Quality of Life)	baseline and 5 years	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	points on a scale	MEAN
PRIMARY	Costs	baseline, 6 and 12 months, 5 and 10 years			NUMBER
SECONDARY	Depression	baseline, 6 and 12 months, 5 and 10 years

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
HRQoL (Health Related Quality of Life)	LNG-IUS		0.08	95% Confidence Interval 0.03 to 0.13	points on a scale
HRQoL (Health Related Quality of Life)	Hysterectomy		0.10	95% Confidence Interval 0.05 to 0.15	points on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	LNG-IUS	119
Overall Study	STARTED	Hysterectomy	117
Overall Study	COMPLETED	LNG-IUS	115
Overall Study	COMPLETED	Hysterectomy	114
Overall Study	NOT COMPLETED	LNG-IUS	4
Overall Study	NOT COMPLETED	Hysterectomy	3

Source ClinicalTrials.gov

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	hormonal symptoms	Surgical and medical procedures	LNG-IUS	18	119	18
other	hormonal symptoms	Surgical and medical procedures	Hysterectomy	0	117	0
other	menstrual bleeding problems	Surgical and medical procedures	LNG-IUS	61	119	61
other	menstrual bleeding problems	Surgical and medical procedures	Hysterectomy	2	117	2
other	wund infection	Surgical and medical procedures	LNG-IUS	9	50	9
other	wund infection	Surgical and medical procedures	Hysterectomy	20	109	20
other	perioperative bleeding	Surgical and medical procedures	LNG-IUS	1	50	1
other	perioperative bleeding	Surgical and medical procedures	Hysterectomy	1	109	1
other	postoperative bleeding	Surgical and medical procedures	LNG-IUS	1	50	1
other	postoperative bleeding	Surgical and medical procedures	Hysterectomy	2	109	2

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected
Total, all-cause mortality	LNG-IUS
Total, all-cause mortality	Hysterectomy
Total, other adverse events	LNG-IUS	80
Total, other adverse events	Hysterectomy	25
Total, serious adverse events	LNG-IUS	0
Total, serious adverse events	Hysterectomy	5

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00966264

GET https://conductscience.org/api/trials/v1/NCT00966264/registered

API reference For AI assistants