check_circleStudy Completed

Menopause

Bayer Identifier:

90660

ClinicalTrials.gov Identifier:

NCT00185458

EudraCT Number:

Not Available

EU CT Number:

Not Available
Assessment of the transfer of using levonorgestrel intrauterine system (LNG IUS) as a contraceptive to using it as part of hormone replacement therapy (HRT).

Trial 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.

Key Participants Requirements

Sex

Female

Age

46 - 51 Years
  • - Women with intact uterus, regular menstrual cycles and no previous or current climacteric symptoms.
  • - Pregnancy or lactation.
    - Previous pelvic infections.
    - Abnormal bleeding.
    - Abnormal uterine cavity.
    - Uterine polyps.
    - Genital cancer.
    - Liver diseases.
    - Alcoholism or drug abuse.

Trial summary

Enrollment Goal
394
Trial Dates
May 2000 - May 2008
Phase
Phase 3
Could I Receive a placebo
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Atrium Medisch Centrum ParkstadHeerlen, 6419 PC, Netherlands
Completed
VieCuri - Medisch Centrum voor Noord-Limburg locatie VenloVENLO, 5912 BL, Netherlands
Completed
Adenova Lääkärikeskus OyEspoo, 02100, Finland
Completed
Turun Gynekologikeskus OyTurku, 20100, Finland
Completed
Newcastle General HospitalNewcastle upon Tyne, NE4 6BE, United Kingdom
Completed
Poole Hospital NHS TrustPoole, BH15 2JB, United Kingdom
Completed
Dr. D. LeonardHUY, 4500, Belgium
Completed
UZ GentGent, 9000, Belgium
Completed
Turun yliopistollinen keskussairaala, kantasairaalaTurku, 20520, Finland
Completed
LCG Bioscience Bourn Hall ClinicCambridge, CB23 2TN, United Kingdom
Completed
Zaans Medisch CentrumZaandam, 1502 DV, Netherlands
Completed
Albert Schweitzer Ziekenhuis, locatie ZwijndrechtZwijndrecht, 3331 LZ, Netherlands

Primary Outcome

  • Number of Bleeding Days
    date_rangeTime Frame:
    Last 90 days in Contraception Phase and first 360 days in Hormone-Replacement Therapy (HRT) Phase
    enhanced_encryption
    Safety Issue:
    No
  • Number of Spotting Days
    date_rangeTime Frame:
    Last 90 days in Contraception Phase and first 360 days in HRT Phase
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of Participants With Successful Treatment
    date_rangeTime Frame:
    Last 90 days in Contraception Phase and first 360 days in HRT Phase
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Assessment of QOL as Measured by Women's Health Questionnaire
    date_rangeTime Frame:
    Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
    enhanced_encryption
    Safety Issue:
    No
  • Continuation Rates
    date_rangeTime Frame:
    At entry, at 2 years, at 4 years
    enhanced_encryption
    Safety Issue:
    No
  • Progestogenic Symptom 1: Headache (as Measured by a Visual Analogue Scale (VAS))
    date_rangeTime Frame:
    Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
    enhanced_encryption
    Safety Issue:
    No
  • Progestogenic Symptom 2: Depressive Mood (as Measured by a VAS)
    date_rangeTime Frame:
    Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
    enhanced_encryption
    Safety Issue:
    No
  • Progestogenic Symptom 3: Acne or Greasy Skin (as Measured by a VAS)
    date_rangeTime Frame:
    Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
    enhanced_encryption
    Safety Issue:
    No
  • Progestogenic Symptom 4: Nausea (as Measured by a VAS)
    date_rangeTime Frame:
    Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
    enhanced_encryption
    Safety Issue:
    No
  • Progestogenic Symptom 5: Edema (as Measured by a VAS)
    date_rangeTime Frame:
    Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
    enhanced_encryption
    Safety Issue:
    No
  • Progestogenic Symptom 6: Decreased Libido (as Measured by a VAS)
    date_rangeTime Frame:
    Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
    enhanced_encryption
    Safety Issue:
    No
  • Climacteric Symptom 1: Hot Flushes (as Measured by a VAS)
    date_rangeTime Frame:
    Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
    enhanced_encryption
    Safety Issue:
    No
  • Climacteric Symptom 2: Sweating Episodes (as Measured by a VAS)
    date_rangeTime Frame:
    Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
    enhanced_encryption
    Safety Issue:
    No
  • Climacteric Symptom 3: Vaginal Dryness (as Measured by a VAS)
    date_rangeTime Frame:
    Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
    enhanced_encryption
    Safety Issue:
    No
  • Climacteric Symptom 4: Sleep Problems (as Measured by a VAS)
    date_rangeTime Frame:
    Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
    enhanced_encryption
    Safety Issue:
    No
  • Climacteric Symptom 5: Irritability (as Measured by a VAS)
    date_rangeTime Frame:
    Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
    enhanced_encryption
    Safety Issue:
    No
  • Climacteric Symptom 6: Breast Tension (as Measured by a VAS)
    date_rangeTime Frame:
    Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
    enhanced_encryption
    Safety Issue:
    No
  • Progestogenic Symptom 7: Hair Loss (as Measured by a VAS)
    date_rangeTime Frame:
    Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
    enhanced_encryption
    Safety Issue:
    No
  • Progestogenic Symptom 8: Greasy Hair (as Measured by a VAS)
    date_rangeTime Frame:
    Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
    enhanced_encryption
    Safety Issue:
    No

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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