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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00185458
First received: September 13, 2005
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Menopause
Drug: LNG IUS
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of Bleeding Days [ Time Frame: Last 90 days in Contraception Phase and first 360 days in Hormone-Replacement Therapy (HRT) Phase ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Continuation Rates [ Time Frame: At entry, at 2 years, at 4 years ] [ Designated as safety issue: No ]
    Percentage of subjects continuing in the study at the given time points.

  • 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 ] [ Designated as safety issue: No ]
    Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

  • 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 ] [ Designated as safety issue: No ]
    Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

  • 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 ] [ Designated as safety issue: No ]
    Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

  • 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 ] [ Designated as safety issue: No ]
    Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

  • 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 ] [ Designated as safety issue: No ]
    Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

  • 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 ] [ Designated as safety issue: No ]
    Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

  • 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 ] [ Designated as safety issue: No ]
    Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

  • 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 ] [ Designated as safety issue: No ]
    Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

  • 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 ] [ Designated as safety issue: No ]
    Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

  • 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 ] [ Designated as safety issue: No ]
    Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

  • 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 ] [ Designated as safety issue: No ]
    Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

  • 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 ] [ Designated as safety issue: No ]
    Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

  • 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 ] [ Designated as safety issue: No ]
    Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

  • 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 ] [ Designated as safety issue: No ]
    Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.


Enrollment: 394
Study Start Date: May 2000
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   46 Years to 51 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185458

Locations
Belgium
Gent, Belgium, 9000
HUY, Belgium, 4500
Finland
Espoo, Finland, 02100
Turku, Finland, 20100
Turku, Finland, 20520
Netherlands
Heerlen, Netherlands, 6419 PC
Venlo, Netherlands, 5912 BL
Zaandam, Netherlands, 1502 DV
Zwijndrecht, Netherlands, 3331 LZ
United Kingdom
Cambridge, Cambridgeshire, United Kingdom, CB23 2TN
Poole, Dorset, United Kingdom, BH15 2JB
Newcastle upon Tyne, United Kingdom, NE4 6BE
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00185458     History of Changes
Other Study ID Numbers: 90660, 300400
Study First Received: September 13, 2005
Results First Received: July 23, 2009
Last Updated: November 5, 2013
Health Authority: Finland: Finnish Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on August 28, 2014