Clinical trial 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).
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Menopause
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 394
Sex: FEMALE
Minimum age (years): 46
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Number of Bleeding Days
timeFrame: Last 90 days in Contraception Phase and first 360 days in Hormone-Replacement Therapy (HRT) Phase
measure: Number of Spotting Days
timeFrame: Last 90 days in Contraception Phase and first 360 days in HRT Phase
measure: Percentage of Participants With Successful Treatment
timeFrame: Last 90 days in Contraception Phase and first 360 days in HRT Phase
Secondary outcomes:
measure: Assessment of QOL as Measured by Women's Health Questionnaire
timeFrame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
measure: Continuation Rates
timeFrame: At entry, at 2 years, at 4 years
measure: Progestogenic Symptom 1: Headache (as Measured by a Visual Analogue Scale (VAS))
timeFrame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
measure: Progestogenic Symptom 2: Depressive Mood (as Measured by a VAS)
timeFrame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
measure: Progestogenic Symptom 3: Acne or Greasy Skin (as Measured by a VAS)
timeFrame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
measure: Progestogenic Symptom 4: Nausea (as Measured by a VAS)
timeFrame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
measure: Progestogenic Symptom 5: Edema (as Measured by a VAS)
timeFrame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
measure: Progestogenic Symptom 6: Decreased Libido (as Measured by a VAS)
timeFrame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
measure: Climacteric Symptom 1: Hot Flushes (as Measured by a VAS)
timeFrame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
measure: Climacteric Symptom 2: Sweating Episodes (as Measured by a VAS)
timeFrame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
measure: Climacteric Symptom 3: Vaginal Dryness (as Measured by a VAS)
timeFrame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
measure: Climacteric Symptom 4: Sleep Problems (as Measured by a VAS)
timeFrame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
measure: Climacteric Symptom 5: Irritability (as Measured by a VAS)
timeFrame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
measure: Climacteric Symptom 6: Breast Tension (as Measured by a VAS)
timeFrame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
measure: Progestogenic Symptom 7: Hair Loss (as Measured by a VAS)
timeFrame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
measure: Progestogenic Symptom 8: Greasy Hair (as Measured by a VAS)
timeFrame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
Other outcomes:
Locations:
city: Gent
country: Belgium
city: HUY
country: Belgium
city: Espoo
country: Finland
city: Turku
country: Finland
city: Turku
country: Finland
city: Heerlen
country: Netherlands
city: Venlo
country: Netherlands
city: Zaandam
country: Netherlands
city: Zwijndrecht
country: Netherlands
city: Cambridge
country: United Kingdom
state: Cambridgeshire
city: Poole
country: United Kingdom
state: Dorset
city: Newcastle upon Tyne
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.