Heavy Menstrual BleedingPhase 3LVS-20NCT01695902
Therapeutic Equivalence Trial of Two Hormonal-IUDs in Patients With Heavy Menstrual Bleeding
A Phase 3 study testing Levosert-20 and Mirena in people with Heavy Menstrual Bleeding, run by Uteron Pharma S.A..
Trial summary
The primary objective of this study was to compare the efficacy of Test Product (Levosert) vs. Reference Product (Mirena® Bayer-Schering) based on the mean variation of menstrual blood loss volume in women with menorrhagia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Heavy Menstrual Bleeding
- What is being tested?
- Levosert-20 and Mirena
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Dec 2007to Sep 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-pregnant, non-planning pregnancy, non-lactating non-menopausal females at least 18 years of age.
- Patients with a clinical diagnosis of functional Menorrhagia during the last 6 months.
- Patients who are eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained to them.
Who cannot join
- History of endometrial ablation or dilatation and/or curettage within the 3 months prior to screening
- Copper - coiled-intrauterine device or LNG releasing IUS use within 2 months prior to screening
- Abnormal liver function or jaundice
- Renal insufficiency
- Other hormonal treatment (sexual steroids),
- Organic causes of abnormal uterine bleeding (presence of endometrial polyps, submucous myomas of any size, or myometrial myomas > than 3 cm, adenomyosis, atypical hyperplasia, carcinoma)
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- Abnormal uterine morphology
- Presence of ovarian cyst > 3 cm
- Lower genital tract infection
- Current or recurrent PID (present or recurrent pelvis infection (including history of postpartum endometritis, infected miscarriage) during the past 3 months
- Uncontrolled hypertension
- Congenital or acquired valvular disease (including corrections with prosthetic valves)
- Known or suspected pregnancy
- Known or suspected hormone-dependent tumor
- BMI > 30
- Abnormal Pap smear test or other evidence of cervical/endometrial mancy
- Unexplained amenorrhea
- Known hypersensitivity to device material and/or Levonorgestrel
About this study
Official title: A Multiple Center, Randomised, Parallel Group, Single-blind Clinical Trial, to Assess the Therapeutic Equivalence in Terms of Efficacy and Safety of Test Product (Levosert) and Reference Product (Mirena®) in Patients With Menorrhagia - Phase III (Therapeutic Equivalence).
The primary objective of this study was to compare the efficacy of Test Product (Levosert) vs. Reference Product (Mirena® Bayer-Schering) based on the mean variation of menstrual blood loss volume in women with menorrhagia.
The secondary objectives includes physical and gynaecological examinations, vital signs, clinical laboratory tests including hemoglobin and ferritin measurements, body weight and spontaneously reported adverse events were analysed and compared between Levosert and Mirena® treatment arms. Plasma levels of levonorgestrel (LNG) were also evaluated after various periods of time. The residual amounts of LNG in the devices were finally measured after withdrawal at completion of the study. Plasma levels of LNG and residual amounts of LNG were compared between the two treatment groups. Contraceptive effect of Levosert was estimated by Pearl Index.
- Conditions
- Heavy Menstrual Bleeding
- Being tested
- Levosert-20, Mirena
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levosert-20Drug
MirenaDrug
| Study group | Role | What they receive |
|---|---|---|
| Levosert-20 | Experimental | Levosert is a LNG-releasing Intrauterine Delivery System (IUS) containing 52 mg of LNG in a cylindrical-shaped reservoir. The reservoir is mounted on the vertical arm of a T-shaped plastic frame and is covered with a release rate controlling membrane. Receives: Drug: Levosert-20 |
| Mirena® | Active comparator | Mirena® IUS, Bayer-Schering, a LNG-releasing Intrauterine Delivery System (IUS) containing 52 mg of LNG. Receives: Drug: Mirena |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline to Year 1 in the mean menstrual blood loss volume measured using the modified Wyatt pictogram in the two treatment groups
Measured: 1 year
Secondary outcomes (3)
Comparison of the plasma levels of LNG (Levonorgestrel) in the 2 treatment groups
Measured: up to three years
Comparison of the residual LNG level in the IUS in the 2 treatment groups
Measured: up to three years
Mean reduction in menstrual blood loss volume from baseline to intermediate cycles (equivalent to 28-days period)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startDec 2007
- Primary completionJan 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy Menstrual BleedingStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uteron Pharma S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695902
- Sponsor's protocol ID
- 2007-001564-77
- Acronym
- LVS-20
- Status last verified
- Sep 2012
- First submitted
- 27 Sep 2012
- Last updated
- 28 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Center, Randomised, Parallel Group, Single-blind Clinical Trial, to Assess the Therapeutic Equivalence in Terms of Efficacy and Safety of Test Product (Levosert) and Reference Product (Mirena®) in Patients With Menorrhagia - Phase III (Therapeutic Equivalence).
- ClinicalTrials.gov ID
- NCT01695902
- Acronym / sponsor ID
- LVS-20 / 2007-001564-77
- Conditions
- Heavy Menstrual Bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Uteron Pharma S.A.Industry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 28 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study was to compare the efficacy of Test Product (Levosert) vs. Reference Product (Mirena® Bayer-Schering) based on the mean variation of menstrual blood loss volume in women with menorrhagia.
The secondary objectives includes physical and gynaecological examinations, vital signs, clinical laboratory tests including hemoglobin and ferritin measurements, body weight and spontaneously reported adverse events were analysed and compared between Levosert and Mirena® treatment arms. Plasma levels of levonorgestrel (LNG) were also evaluated after various periods of time. The residual amounts of LNG in the devices were finally measured after withdrawal at completion of the study. Plasma levels of LNG and residual amounts of LNG were compared between the two treatment groups. Contraceptive effect of Levosert was estimated by Pearl Index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levosert-20 | Experimental | Drug: Levosert-20Levosert is a LNG-releasing Intrauterine Delivery System (IUS) containing 52 mg of LNG in a cylindrical-shaped reservoir. The reservoir is mounted on the vertical arm of a T-shaped plastic frame and is covered with a release rate controlling membrane. |
| Mirena® | Active comparator | Drug: MirenaMirena® IUS, Bayer-Schering, a LNG-releasing Intrauterine Delivery System (IUS) containing 52 mg of LNG. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-pregnant, non-planning pregnancy, non-lactating non-menopausal females at least 18 years of age.
- Patients with a clinical diagnosis of functional Menorrhagia during the last 6 months.
- Patients who are eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained to them.
Key exclusion criteria (18 listed)
- History of endometrial ablation or dilatation and/or curettage within the 3 months prior to screening
- Copper - coiled-intrauterine device or LNG releasing IUS use within 2 months prior to screening
- Abnormal liver function or jaundice
- Renal insufficiency
- Other hormonal treatment (sexual steroids),
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 |
|---|---|---|
| Levosert-20 | Drug | Levosert-20 |
| Mirena | Drug | Mirena® |
Primary outcome
Mean change from baseline to Year 1 in the mean menstrual blood loss volume measured using the modified Wyatt pictogram in the two treatment groups
Time frame: 1 year
3 secondary outcomes
Comparison of the plasma levels of LNG (Levonorgestrel) in the 2 treatment groups
Time frame: up to three years
Comparison of the residual LNG level in the IUS in the 2 treatment groups
Time frame: up to three years
Mean reduction in menstrual blood loss volume from baseline to intermediate cycles (equivalent to 28-days period)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levosert-20 and Mirena in people with Heavy Menstrual Bleeding, run by Uteron Pharma S.A..
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 3 inclusion and 18 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 28 Sep 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change from baseline to Year 1 in the mean menstrual blood loss volume measured using the modified Wyatt pictogram in the two treatment groups (time frame: 1 year). 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 28 Sep 2012; AzTrials last refreshed its copy on 8 Nov 2026.