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Completed

NCT Number: NCT00185458

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

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.

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Key information

Conditions

Menopause

Age range

46 year–51 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ghent, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LNG IUS

Drug

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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

Secondary outcomes

  1. 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.

  2. Continuation Rates

    Time frame: At entry, at 2 years, at 4 years

    Percentage of subjects continuing in the study at the given time points.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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.

Important dates

Study start
2000
Primary completion
2008
Study completion
2008
First posted
Sep 16, 2005
Registry last updated
Nov 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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