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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00185458
First received: September 13, 2005
Last updated: November 22, 2012
Last verified: November 2012
History of Changes
Results First Received: July 23, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Menopause
Intervention: Drug: LNG IUS

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Only the subjects who reached menopause within max. of 4 years of the contraception phase were eligible for the Hormone-Replacement Therapy (HRT) phase. 58 subjects discontinued the study during the contraception phase before starting the HRT, and 168 subjects who started treatment did not reach menopause.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
489 subjects were screened: 394 subjects started treatment and 95 subjects failed screening. Intent-to-treat (ITT) population included all subjects (N=394) who had the LNG IUS inserted, or for whom the insertion was attempted. 322 subjects without major protocol deviations were included in the Per protocol set (PPS).

Reporting Groups
  Description
LNG IUS 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.

Participant Flow for 2 periods

 Period 1:   Contraception Phase
    LNG IUS  
STARTED     394  
COMPLETED     336  
NOT COMPLETED     58  
Adverse Event                 37  
Lost to Follow-up                 10  
Protocol Violation                 2  
Physician Decision                 2  
Withdrawal by Subject                 7  

Period 2:   HRT Phase
    LNG IUS  
STARTED     168 [1]
COMPLETED     141  
NOT COMPLETED     27  
Adverse Event                 18  
Lost to Follow-up                 4  
Protocol Violation                 2  
Withdrawal by Subject                 3  
[1] 168 subjects were eligible for the HRT phase out 336 who completed contraception phase.



  Baseline Characteristics
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Reporting Groups
  Description
LNG IUS 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.

Baseline Measures
    LNG IUS  
Number of Participants  
[units: participants]
 		  394  
Age  
[units: years]
Mean ± Standard Deviation 		  47.8  ± 1.42  
Gender  
[units: participants]
 		 
Female     394  
Male     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Bleeding Days   [ Time Frame: Last 90 days in Contraception Phase and first 360 days in Hormone-Replacement Therapy (HRT) Phase ]
  Show Outcome Measure 1

2.  Primary:   Number of Spotting Days   [ Time Frame: Last 90 days in Contraception Phase and first 360 days in HRT Phase ]
  Show Outcome Measure 2

3.  Primary:   Percentage of Participants With Successful Treatment   [ Time Frame: Last 90 days in Contraception Phase and first 360 days in HRT Phase ]
  Show Outcome Measure 3

4.  Secondary:   Assessment of QOL as Measured by Women's Health Questionnaire   [ Time Frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase ]
  Show Outcome Measure 4

5.  Secondary:   Continuation Rates   [ Time Frame: At entry, at 2 years, at 4 years ]
  Show Outcome Measure 5

6.  Secondary:   Progestogenic Symptom 1: Headache (as Measured by a Visual Analogue Scale (VAS))   [ Time Frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase ]
  Show Outcome Measure 6

7.  Secondary:   Progestogenic Symptom 2: Depressive Mood (as Measured by a VAS)   [ Time Frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase ]
  Show Outcome Measure 7

8.  Secondary:   Progestogenic Symptom 3: Acne or Greasy Skin (as Measured by a VAS)   [ Time Frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase ]
  Show Outcome Measure 8

9.  Secondary:   Progestogenic Symptom 4: Nausea (as Measured by a VAS)   [ Time Frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase ]
  Show Outcome Measure 9

10.  Secondary:   Progestogenic Symptom 5: Edema (as Measured by a VAS)   [ Time Frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase ]
  Show Outcome Measure 10

11.  Secondary:   Progestogenic Symptom 6: Decreased Libido (as Measured by a VAS)   [ Time Frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase ]
  Show Outcome Measure 11

12.  Secondary:   Climacteric Symptom 1: Hot Flushes (as Measured by a VAS)   [ Time Frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase ]
  Show Outcome Measure 12

13.  Secondary:   Climacteric Symptom 2: Sweating Episodes (as Measured by a VAS)   [ Time Frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase ]
  Show Outcome Measure 13

14.  Secondary:   Climacteric Symptom 3: Vaginal Dryness (as Measured by a VAS)   [ Time Frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase ]
  Show Outcome Measure 14

15.  Secondary:   Climacteric Symptom 4: Sleep Problems (as Measured by a VAS)   [ Time Frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase ]
  Show Outcome Measure 15

16.  Secondary:   Climacteric Symptom 5: Irritability (as Measured by a VAS)   [ Time Frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase ]
  Show Outcome Measure 16

17.  Secondary:   Climacteric Symptom 6: Breast Tension (as Measured by a VAS)   [ Time Frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase ]
  Show Outcome Measure 17

18.  Secondary:   Progestogenic Symptom 7: Hair Loss (as Measured by a VAS)   [ Time Frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase ]
  Show Outcome Measure 18

19.  Secondary:   Progestogenic Symptom 8: Greasy Hair (as Measured by a VAS)   [ Time Frame: Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase ]
  Show Outcome Measure 19


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


Publications of Results:


Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00185458     History of Changes
Other Study ID Numbers: 90660, 300400
Study First Received: September 13, 2005
Results First Received: July 23, 2009
Last Updated: November 22, 2012
Health Authority: Finland: Finnish Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency