MenorrhagiaPhase 3VUOKKONCT00966264

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

A Phase 3 study testing LNG-IUS and Hysterectomy in people with Menorrhagia, run by University of Helsinki.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 35 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for: Menorrhagia
What is being tested?: LNG-IUS and Hysterectomy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 236 participants
Where: No sites listed yet
Study dates: Oct 1994to Oct 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 49 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

heavy menstrual bleeding
35-49 years
were menstruating
had completed their family size
were eligible for both treatments

Who cannot join

submucous fibroids
endometrial polyps
ovarian tumours or cysts,
cervical pathology
urinary and bowel symptoms or pain due to large fibroids
lack of indication for hysterectomy

Show all 13Show fewer

history of malignancies
menopause
severe depression
metrorrhagia as a main complaint
previous treatment failure with LNG-IUS
severe acne
uterine malformation

About this study

Official title: Hysterectomy and Levonorgestrel-releasing IUS in the Treatment of Menorrhagia

A randomised study including 236 women referred for essential menorrhagia to five university hospitals in Finland was conducted to compare the cost-effectiveness and the quality of life issues in the treatment of menorrhagia.Participants were randomly assigned to treatment with LNG-IUS (n=119), or hysterectomy (n=117), and were monitored for ten years. The primary outcome measures were health related quality of life (HRQoL), other measures of psychosocial well-being (anxiety, depression, sexual functioning), and costs.

Read the detailed description

A randomized VUOKKO trial was conducted between 1994-2008 to study hysterectomy and LNG-IUS in the treatment of menorrhagia.Overall, 236 women aged 35 to 49 years who were menstruating, had completed their family size, and were eligible for both treatments were randomized to either receive a LNG-IUS (n=119) or undergo hysterectomy (n=117). The follow-up visits took place six months and 12 months after the treatment, and again five and ten years after the randomization. The primary outcome measures were health related quality of life (HRQoL), other measures of psychosocial well-being (anxiety, depression, sexual functioning), and costs. The amount of menstrual blood loss was objectively measured before treatment and after one and five years. The one year the results were published in 2001 (Lancet 2001;357:273) and the five year results in 2004 (JAMA 2004; 291:1456).

Conditions: Menorrhagia
Being tested: LNG-IUS, Hysterectomy
Keywords: randomized controlled trial, menorrhagia, LNG-IUS, hysterectomy
Medical subject headings: Menorrhagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LNG-IUSDrug
Also called Mirena
LNG-IUS releasing 25 microg of levonorgestrel
HysterectomyProcedure or surgery
Also called Removal of uterus by laparoscopy, vaginally or abdominally
operation

Study groups in NCT00966264
Study group	Role	What they receive
LNG-IUS	Active comparator	Levonorgestrel releasing intrauterine system Receives: Drug: LNG-IUS; Procedure: Hysterectomy
Hysterectomy	Other	Hysterectomy Receives: Drug: LNG-IUS; Procedure: Hysterectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

HRQoL (Health Related Quality of Life)
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)
Measured: baseline and 5 years
Costs
Measured: baseline, 6 and 12 months, 5 and 10 years

Secondary outcomes (1)

Depression
Measured: baseline, 6 and 12 months, 5 and 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 1994Oct 2008

First posted26 Aug 2009 (estimated)
Study startOct 1994
Primary completionOct 2008
Study completionOct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MenorrhagiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 236 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00966264
Sponsor's protocol ID: Finnish Academy-project 29168
Acronym: VUOKKO
Status last verified: Aug 2009
First submitted: 20 Jan 2009
Last updated: 2 Sep 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
Heavy Menstrual Bleeding, Bleeding Disorder
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Recruiting
A Clinical Study of the Aqua Therapeutics Thermal Therapy Vapor Ablation System in Premenopausal Women With Abnormal Uterine Bleeding
Menorrhagia
RecruitingPhase 2
HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
Von Willebrand Disease (VWD), Heavy Menstrual Bleeding (HMB)
Recruiting
Delivering tAN to Reduce HMB: The LUNA Study
Heavy Menstrual Bleeding

All Menorrhagia trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hysterectomy and Levonorgestrel-releasing IUS in the Treatment of Menorrhagia
ClinicalTrials.gov ID: NCT00966264
Acronym / sponsor ID: VUOKKO / Finnish Academy-project 29168
Conditions: Menorrhagia
Keywords: randomized controlled trial, menorrhagia, LNG-IUS, hysterectomy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 236 participants (actual)
Lead sponsor: University of HelsinkiUniversity, hospital or other
Collaborators: University of Eastern Finland, University of Oulu, Tampere University, University of Turku
Study start: Oct 1994
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 26 Aug 2009 (estimated)
Results: Posted 26 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
LNG-IUS	Active comparator	Drug: LNG-IUS, Procedure: HysterectomyLevonorgestrel releasing intrauterine system
Hysterectomy	Other	Drug: LNG-IUS, Procedure: HysterectomyHysterectomy

Who may qualify

Ages: 35 to 49 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

heavy menstrual bleeding
35-49 years
were menstruating
had completed their family size
were eligible for both treatments

Key exclusion criteria (13 listed)

submucous fibroids
endometrial polyps
ovarian tumours or cysts,
cervical pathology
urinary and bowel symptoms or pain due to large fibroids

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LNG-IUSAlso: MirenaLNG-IUS releasing 25 microg of levonorgestrel	Drug	Hysterectomy, LNG-IUS
HysterectomyAlso: Removal of uterus by laparoscopy, vaginally or abdominallyoperation	Procedure or surgery	Hysterectomy, LNG-IUS

Primary outcome

HRQoL (Health Related Quality of Life)
Time frame: 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)
Costs
Time frame: baseline, 6 and 12 months, 5 and 10 years

1 secondary outcome

Depression
Time frame: baseline, 6 and 12 months, 5 and 10 years

Results and safety

Results posted to the registry on 26 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LNG-IUS	119	115
Hysterectomy	117	114

Primary outcome: HRQoL (Health Related Quality of Life)

Time frame: baseline and 5 years. Mean (95% Confidence Interval). Unit: points on a scale

Measure	LNG-IUS n = 115	Hysterectomy n = 114
Value	0.08 (0.03 to 0.13)	0.10 (0.05 to 0.15)

Population analysed: 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

Primary outcome: Costs

Time frame: baseline, 6 and 12 months, 5 and 10 years. Number

The sponsor has not posted figures for this outcome.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 20% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LNG-IUS	0 of ?	80 of ?	Not reported
Hysterectomy	5 of ?	25 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Menorrhagia

RecruitingObservational study
Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
Heavy Menstrual Bleeding, Bleeding Disorder
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Recruiting
A Clinical Study of the Aqua Therapeutics Thermal Therapy Vapor Ablation System in Premenopausal Women With Abnormal Uterine Bleeding
Menorrhagia
RecruitingPhase 2
HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
Von Willebrand Disease (VWD), Heavy Menstrual Bleeding (HMB)
Recruiting
Delivering tAN to Reduce HMB: The LUNA Study
Heavy Menstrual Bleeding

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ritva S Hurskainen, MD, PhD principal investigator

Helsinki University Central Hospital

Jorma Paavonen, prof study director

University of Helsinki

Juha Teperi, prof study chair

National Istitute For Health and Welfare, Finland

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LNG-IUS and Hysterectomy in people with Menorrhagia, run by University of Helsinki.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HRQoL (Health Related Quality of Life) (time frame: baseline and 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00966264.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2009.