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

Menopause Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185458
• Other study ID #: 90660
• Secondary ID: 300400
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: November 5, 2013
• Start date: May 2000
• Est. completion date: May 2008

Study information

• Verified date: November 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 46 Years to 51 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Menopause

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Belgium,  Finland,  Netherlands,  United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Bleeding Days	Measured by using Subject Diaries (Subject Reported Data)	Last 90 days in Contraception Phase and first 360 days in Hormone-Replacement Therapy (HRT) Phase	No
Primary	Number of Spotting Days	Measured by using Subject Diaries (Subject Reported Data)	Last 90 days in Contraception Phase and first 360 days in HRT Phase	No
Primary	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	Last 90 days in Contraception Phase and first 360 days in HRT Phase	No
Secondary	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.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	No
Secondary	Continuation Rates	Percentage of subjects continuing in the study at the given time points.	At entry, at 2 years, at 4 years	No
Secondary	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.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	No
Secondary	Progestogenic Symptom 2: Depressive Mood (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	No
Secondary	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.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	No
Secondary	Progestogenic Symptom 4: Nausea (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	No
Secondary	Progestogenic Symptom 5: Edema (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	No
Secondary	Progestogenic Symptom 6: Decreased Libido (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	No
Secondary	Climacteric Symptom 1: Hot Flushes (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	No
Secondary	Climacteric Symptom 2: Sweating Episodes (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	No
Secondary	Climacteric Symptom 3: Vaginal Dryness (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	No
Secondary	Climacteric Symptom 4: Sleep Problems (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	No
Secondary	Climacteric Symptom 5: Irritability (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	No
Secondary	Climacteric Symptom 6: Breast Tension (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	No
Secondary	Progestogenic Symptom 7: Hair Loss (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	No
Secondary	Progestogenic Symptom 8: Greasy Hair (as Measured by a VAS)	Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.	Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase	No

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