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

NCT00185458 | Completed Phase 3 Results

• 2 other identifiers: 90660300400
• Study Type: interventional
• Target: 394
• Locations: 4 countries
• Sites: 12

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.

Conditions

Menopause

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (16)

• Assessment of QOL as Measured by Women's Health Questionnaire

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

• Continuation Rates

  At entry, at 2 years, at 4 years

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

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

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

  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)

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

Study Arms (1)

LNG IUS

EXPERIMENTAL

Levonorgestrel Intrauterine System (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) Hormone-Replacement Therapy (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 World Health Organization (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.

Drug: LNG IUS

Interventions

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.

LNG IUS

Eligibility Criteria

• Age: 46 Years - 51 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with intact uterus, regular menstrual cycles and no previous or current climacteric symptoms.

You may not qualify if:

• Pregnancy or lactation.
• Previous pelvic infections.
• Abnormal bleeding.
• Abnormal uterine cavity.
• Uterine polyps.
• Genital cancer.
• Liver diseases.
• Alcoholism or drug abuse.

Sponsors & Collaborators

• Bayer: lead

Study Sites (12)

Unknown Facility

Ghent, 9000, Belgium

Location

Unknown Facility

Huy, 4500, Belgium

Location

Unknown Facility

Espoo, 02100, Finland

Location

Unknown Facility

Turku, 20100, Finland

Location

Unknown Facility

Turku, 20520, Finland

Location

Unknown Facility

Heerlen, 6419 PC, Netherlands

Location

Unknown Facility

Venlo, 5912 BL, Netherlands

Location

Unknown Facility

Zaandam, 1502 DV, Netherlands

Location

Unknown Facility

Zwijndrecht, 3331 LZ, Netherlands

Location

Unknown Facility

Cambridge, Cambridgeshire, CB23 2TN, United Kingdom

Location

Unknown Facility

Poole, Dorset, BH15 2JB, United Kingdom

Location

Unknown Facility

Newcastle upon Tyne, NE4 6BE, United Kingdom

Location

Related 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 Obstet Gynecol Reprod Biol. 2010 Dec;153(2):176-80. doi: 10.1016/j.ejogrb.2010.08.017.

  PMID: 20888118 RESULT

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: May 1, 2000
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: November 27, 2013
• Results First Posted: November 19, 2009

Record last verified: 2013-11

Locations

BE (2); FI (3); GB (3); NL (4)