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

November 5, 2013 updated by: Bayer

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
394

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
      • HUY, Belgium, 4500
  • Finland
      • Espoo, Finland, 02100
      • Turku, Finland, 20520
      • Turku, Finland, 20100
  • Netherlands
      • Heerlen, Netherlands, 6419 PC
      • Venlo, Netherlands, 5912 BL
      • Zaandam, Netherlands, 1502 DV
      • Zwijndrecht, Netherlands, 3331 LZ
  • United Kingdom
      • Newcastle upon Tyne, United Kingdom, NE4 6BE
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB23 2TN
    • Dorset
      • Poole, Dorset, United Kingdom, BH15 2JB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

46 years to 51 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: LNG IUS
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.
Drug: LNG IUS
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Last 90 days in Contraception Phase and first 360 days in Hormone-Replacement Therapy (HRT) Phase
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)
Last 90 days in Contraception Phase and first 360 days in HRT Phase
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
Last 90 days in Contraception Phase and first 360 days in HRT Phase

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
Percentage of subjects continuing in the study at the given time points.
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
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
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
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
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
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
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
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
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
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
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
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
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
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
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
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
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
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
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
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
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
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
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
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
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
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
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
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2000

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2008

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2005

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 90660
  • 300400 (OTHER: Company Internal)

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