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

Bayer394 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

394

Conditions

Menopause

Interventions

LNG IUSDRUG

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.

Eligibility

Sex: FEMALEMin age: 46 YearsMax age: 51 Years

Medical Language ↔ Plain English

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.

Locations (12)

Unnamed facility

Ghent, Belgium

Unnamed facility

Huy, Belgium

Unnamed facility

Espoo, Finland

Unnamed facility

Turku, Finland

Outcomes

Primary Outcomes

Number of Bleeding Days

Measured by using Subject Diaries (Subject Reported Data)

Time frame: Last 90 days in Contraception Phase and first 360 days in Hormone-Replacement Therapy (HRT) Phase

Number of Spotting Days

Measured by using Subject Diaries (Subject Reported Data)

Time frame: Last 90 days in Contraception Phase and first 360 days in HRT Phase

Percentage of Participants With Successful Treatment

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

Time frame: Last 90 days in Contraception Phase and first 360 days in HRT Phase

Secondary Outcomes

Assessment of QOL as Measured by Women's Health Questionnaire

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.

Time frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase

Continuation Rates

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

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

Progestogenic Symptom 1: Headache (as Measured by a Visual Analogue Scale (VAS))

Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

Time frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase

Data from ClinicalTrials.gov

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Unnamed facility

Turku, Finland

Unnamed facility

Heerlen, Netherlands

Unnamed facility

Venlo, Netherlands

Unnamed facility

Zaandam, Netherlands

Unnamed facility

Zwijndrecht, Netherlands

Unnamed facility

Cambridge, Cambridgeshire, United Kingdom

...and 2 more locations

Progestogenic Symptom 2: Depressive Mood (as Measured by a VAS)

Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

Time frame: 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)

Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

Time frame: 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)

Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

Time frame: 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)

Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

Time frame: 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)

Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

Time frame: 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)

Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

Time frame: 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)

Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

Time frame: 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)

Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

Time frame: 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)

Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

Time frame: 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)

Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

Time frame: 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)

Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

Time frame: 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)

Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

Time frame: 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)

Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.

Time frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase