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.
Trial summary
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… Read more about this study
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland, University of Oulu, Tampere University, University of Turku
- Investigators
- Ritva S Hurskainen, MD, PhD, Principal investigator, Helsinki University Central HospitalJorma Paavonen, prof, Study director, University of HelsinkiJuha Teperi, prof, Study chair, National Istitute For Health and Welfare, Finland
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
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.
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.
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).
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
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.
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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?
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.