MenopausePhase 3NCT00185458

Assessment of the Transfer of Using Levonorgestrel Intrauterine System (LNG IUS) as a Contraceptive to Using it as Part of Hormone Replacement Therapy (HRT).

A Phase 3 study testing LNG IUS in people with Menopause, run by Bayer at 12 sites in 4 countries.

Completed

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

Trial summary

The study has been designed to look at the transfer from using LNG IUS for contraception only, in reproductive age to using it for endometrial protection in menopausal age. The main area of interest in the study is the pattern of any vaginal bleeding that occurs. Read more about this study

Who is it for?: Ages 46 to 51 years, women only
Conditions the study is for: Menopause
What is being tested?: LNG IUS
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 394 participants
Where: 12 sitesin 4 countries
Study dates: May 2000to May 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 46 to 51 years
Women only
No healthy volunteers
Adult

Who may be able to join

Women with intact uterus, regular menstrual cycles and no previous or current climacteric symptoms.

Who cannot join

Pregnancy or lactation.
Previous pelvic infections.
Abnormal bleeding.
Abnormal uterine cavity.
Uterine polyps.
Genital cancer.
Liver diseases.
Alcoholism or drug abuse.

Trial locations and contacts

12 sites in 4 countries.

Country

City, postcode or hospital

12 sites in 4 countries

Netherlands4 sites

Study site
Heerlen, 6419 PC
Study site
Venlo, 5912 BL
Study site
Zaandam, 1502 DV
Study site
Zwijndrecht, 3331 LZ

Other trials in Netherlands

Finland3 sites

Study site
Espoo, 02100
Study site
Turku, 20100
Study site
Turku, 20520

Other trials in Finland

United Kingdom3 sites

Study site
Cambridge, Cambridgeshire, CB23 2TN
Study site
Newcastle upon Tyne, NE4 6BE
Study site
Poole, Dorset, BH15 2JB

Other trials in United Kingdom

Belgium2 sites

Study site
Ghent, 9000
Study site
Huy, 4500

Other trials in Belgium

About this study

Official title: A 60-month Non-comparative Study on Bleeding Profiles With Levonorgestrel Intrauterine System in Transition From Reproductive Age Contraception to Menopause Age Endometrial Protection During Estrogen Replacement Therapy.

Read the detailed description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Conditions: Menopause
Being tested: LNG IUS

What participants receive

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

LNG IUSDrug
LNG IUS (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) HRT Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by WHO guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.

Study groups in NCT00185458
Study group	Role	What they receive
LNG IUS	Experimental	Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase. Receives: Drug: LNG IUS

What is being measured

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

Number of Bleeding Days
Measured by using Subject Diaries (Subject Reported Data)
Measured: Last 90 days in Contraception Phase and first 360 days in Hormone-Replacement Therapy (HRT) Phase
Number of Spotting Days
Measured by using Subject Diaries (Subject Reported Data)
Measured: Last 90 days in Contraception Phase and first 360 days in HRT Phase
Percentage of Participants With Successful Treatment
Definition of successful treatment:
- Completion of HRT phase, and
- Both, the number of bleeding days and the number of spotting days during HRT was equal to or less than during contraceptive phase, and
- The number of bleeding days and the number of spotting days could be calculated for at least 3 out of the first 4 reference periods in HRT
Measured: Last 90 days in Contraception Phase and first 360 days in HRT Phase

Secondary outcomes (16)

Assessment of QOL as Measured by Women's Health Questionnaire
Women's Health Questionnaire (Total Score). For the Total score, the minimum is 36 and maximum is 144. A higher score means the distress and dysfunction are less pronounced.
Measured: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Continuation Rates
Percentage of subjects continuing in the study at the given time points.
Measured: At entry, at 2 years, at 4 years
Progestogenic Symptom 1: Headache (as Measured by a Visual Analogue Scale (VAS))
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Measured: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Progestogenic Symptom 2: Depressive Mood (as Measured by a VAS)
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Measured: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Progestogenic Symptom 3: Acne or Greasy Skin (as Measured by a VAS)
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Measured: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Progestogenic Symptom 4: Nausea (as Measured by a VAS)
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Measured: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Progestogenic Symptom 5: Edema (as Measured by a VAS)
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Measured: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Progestogenic Symptom 6: Decreased Libido (as Measured by a VAS)
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Measured: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Climacteric Symptom 1: Hot Flushes (as Measured by a VAS)
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Measured: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Climacteric Symptom 2: Sweating Episodes (as Measured by a VAS)
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Measured: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Climacteric Symptom 3: Vaginal Dryness (as Measured by a VAS)
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Measured: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Climacteric Symptom 4: Sleep Problems (as Measured by a VAS)
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Measured: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Climacteric Symptom 5: Irritability (as Measured by a VAS)
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Measured: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Climacteric Symptom 6: Breast Tension (as Measured by a VAS)
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Measured: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Progestogenic Symptom 7: Hair Loss (as Measured by a VAS)
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Measured: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Progestogenic Symptom 8: Greasy Hair (as Measured by a VAS)
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Measured: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase

Timeline

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

May 2000May 2008

First posted16 Sep 2005 (estimated)
Study startMay 2000
Primary completionMay 2008
Study completionMay 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MenopauseStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 394 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00185458
Sponsor's protocol ID: 90660
Other IDs: 300400
Status last verified: Nov 2013
First submitted: 13 Sep 2005
Last updated: 27 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Depypere HT, Hillard T, Erkkola R, Lukkari-Lax E, Kunz M, Rautiainen P, Schram JH. A 60-month non-comparative study on bleeding profiles with the levonorgestrel intrauterine system from the late transition period to estrogen supplemented menopause. Eur J Obstet Gynecol Reprod Biol. 2010 Dec;153(2):176-80. doi: 10.1016/j.ejogrb.2010.08.017.
PubMed 20888118

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?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 60-month Non-comparative Study on Bleeding Profiles With Levonorgestrel Intrauterine System in Transition From Reproductive Age Contraception to Menopause Age Endometrial Protection During Estrogen Replacement Therapy.
ClinicalTrials.gov ID: NCT00185458
Acronym / sponsor ID: 90660
Conditions: Menopause
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 394 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: May 2000
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 16 Sep 2005 (estimated)
Results: Posted 19 Nov 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

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LNG IUS	Experimental	Drug: LNG IUSLevonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.

Who may qualify

Ages: 46 to 51 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Women with intact uterus, regular menstrual cycles and no previous or current climacteric symptoms.

Key exclusion criteria (8 listed)

Pregnancy or lactation.
Previous pelvic infections.
Abnormal bleeding.
Abnormal uterine cavity.
Uterine polyps.

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 IUSLNG IUS (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) HRT Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by WHO guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.	Drug	LNG IUS

Primary outcome

Number of Bleeding Days
Time frame: Last 90 days in Contraception Phase and first 360 days in Hormone-Replacement Therapy (HRT) Phase
Measured by using Subject Diaries (Subject Reported Data)
Number of Spotting Days
Time frame: Last 90 days in Contraception Phase and first 360 days in HRT Phase
Measured by using Subject Diaries (Subject Reported Data)
Percentage of Participants With Successful Treatment
Time frame: Last 90 days in Contraception Phase and first 360 days in HRT Phase
Definition of successful treatment: * Completion of HRT phase, and * Both, the number of bleeding days and the number of spotting days during HRT was equal to or less than during contraceptive phase, and * The number of bleeding days and the number of spotting days could be calculated for at least 3 out of the first 4 reference periods in HRT

16 secondary outcomes

Assessment of QOL as Measured by Women's Health Questionnaire
Time frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Continuation Rates
Time frame: At entry, at 2 years, at 4 years
Progestogenic Symptom 1: Headache (as Measured by a Visual Analogue Scale (VAS))
Time frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Progestogenic Symptom 2: Depressive Mood (as Measured by a VAS)
Time frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Progestogenic Symptom 3: Acne or Greasy Skin (as Measured by a VAS)
Time frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Progestogenic Symptom 4: Nausea (as Measured by a VAS)
Time frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Progestogenic Symptom 5: Edema (as Measured by a VAS)
Time frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Progestogenic Symptom 6: Decreased Libido (as Measured by a VAS)
Time frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Climacteric Symptom 1: Hot Flushes (as Measured by a VAS)
Time frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Climacteric Symptom 2: Sweating Episodes (as Measured by a VAS)
Time frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Climacteric Symptom 3: Vaginal Dryness (as Measured by a VAS)
Time frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Climacteric Symptom 4: Sleep Problems (as Measured by a VAS)
Time frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Climacteric Symptom 5: Irritability (as Measured by a VAS)
Time frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Climacteric Symptom 6: Breast Tension (as Measured by a VAS)
Time frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Progestogenic Symptom 7: Hair Loss (as Measured by a VAS)
Time frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Progestogenic Symptom 8: Greasy Hair (as Measured by a VAS)
Time frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase

Results and safety

Results posted to the registry on 19 Nov 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	394	336

Primary outcome: Number of Bleeding Days

Time frame: Last 90 days in Contraception Phase and first 360 days in Hormone-Replacement Therapy (HRT) Phase. Median (Inter-Quartile Range). Unit: Bleeding days

Measure	Reference Period -1 (Contraception Phase) n = 165	Reference Period 1 (HRT Phase) n = 154	Reference Period 2 (HRT Phase) n = 151	Reference Period 3 (HRT Phase) n = 141	Reference Period 4 (HRT Phase) n = 132
Value	0 (0 to 2)	0 (0 to 1)	0 (0 to 2)	0 (0 to 0)	0 (0 to 0)

Reference Period -1 (Contraception Phase) vs Reference Period 1 (HRT Phase): p = 0.128, Friedman's two-way ANOVA

Population analysed: Intention to treat population (ITT); all subjects with adequate bleeding diary data. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.

Primary outcome: Number of Spotting Days

Time frame: Last 90 days in Contraception Phase and first 360 days in HRT Phase. Median (Inter-Quartile Range). Unit: Spotting days

Measure	Reference Period -1 (Contraception Phase) n = 165	Reference Period 1 (HRT Phase) n = 154	Reference Period 2 (HRT Phase) n = 151	Reference Period 3 (HRT Phase) n = 141	Reference Period 4 (HRT Phase) n = 132
Value	4 (0 to 11)	4 (0 to 10)	2 (0 to 9)	1 (0 to 5)	0 (0 to 6)

Reference Period -1 (Contraception Phase) vs Reference Period 1 (HRT Phase): p = 0.296, Friedman's two-way ANOVA

Population analysed: ITT; all subjects with adequate bleeding diary data. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.

Primary outcome: Percentage of Participants With Successful Treatment

Time frame: Last 90 days in Contraception Phase and first 360 days in HRT Phase. Number. Unit: Percentage of participants with success

Measure	LNG IUS n = 168
Value	31

Population analysed: ITT; all subjects eligible for the HRT

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: The data covers the entire treatment period (contraception phase + HRT phase).. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LNG IUS	25 of 394 (6.3%)	357 of 394 (90.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20888118Depypere HT, Hillard T, Erkkola R, Lukkari-Lax E, Kunz M, Rautiainen P, Schram JH. A 60-month non-comparative study on bleeding profiles with the levonorgestrel intrauterine system from the late transition period to estrogen supplemented menopause. Eur J Obstet Gynecol Reprod Biol. 2010 Dec;153(2):176-80. doi: 10.1016/j.ejogrb.2010.08.017.

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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.

Bayer Study Director study director

Bayer

12 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LNG IUS in people with Menopause, run by Bayer at 12 sites in 4 countries.

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 1 inclusion and 8 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 27 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Netherlands, Finland, United Kingdom, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

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 19 Nov 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?

Number of Bleeding Days (time frame: Last 90 days in Contraception Phase and first 360 days in Hormone-Replacement Therapy (HRT) Phase). The study lists 3 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 NCT00185458, which also lists 1 linked publication.

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 27 Nov 2013.