Trial Condition(s):
Menopause
Assessment of the transfer of using levonorgestrel intrauterine system (LNG IUS) as a contraceptive to using it as part of hormone replacement therapy (HRT).
Bayer Identifier:
90660
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Atrium Medisch Centrum Parkstad Heerlen, Netherlands, 6419 PC | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations VieCuri - Medisch Centrum voor Noord-Limburg locatie Venlo VENLO, Netherlands, 5912 BL | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Adenova Lääkärikeskus Oy Espoo, Finland, 02100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Turun Gynekologikeskus Oy Turku, Finland, 20100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Newcastle General Hospital Newcastle upon Tyne, United Kingdom, NE4 6BE | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Poole Hospital NHS Trust Poole, United Kingdom, BH15 2JB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. D. Leonard HUY, Belgium, 4500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Gent Gent, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Turun yliopistollinen keskussairaala, kantasairaala Turku, Finland, 20520 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations LCG Bioscience Bourn Hall Clinic Cambridge, United Kingdom, CB23 2TN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Zaans Medisch Centrum Zaandam, Netherlands, 1502 DV | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Albert Schweitzer Ziekenhuis, locatie Zwijndrecht Zwijndrecht, Netherlands, 3331 LZ | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Number of Bleeding DaysTimeframe: Last 90 days in Contraception Phase and first 360 days in Hormone-Replacement Therapy (HRT) Phase
- Number of Spotting DaysTimeframe: Last 90 days in Contraception Phase and first 360 days in HRT Phase
- Percentage of Participants With Successful TreatmentTimeframe: Last 90 days in Contraception Phase and first 360 days in HRT Phase
Secondary Outcome
- Assessment of QOL as Measured by Women's Health QuestionnaireTimeframe: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase
- Continuation RatesTimeframe: At entry, at 2 years, at 4 years
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Additional Information
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