Assessment of the Transfer of Using Levonorgestrel Intrauterine System (LNG IUS) as a Contraceptive to Using it as Part of Hormone Replacement Therapy (HRT).
Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT00185458
Collaborator
(none)
394
12
1
96
32.8
0.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed 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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
394 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Study Start Date
:
May 1, 2000
Actual Primary Completion Date
:
May 1, 2008
Actual Study Completion Date
:
May 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- Number of Bleeding Days [Last 90 days in Contraception Phase and first 360 days in Hormone-Replacement Therapy (HRT) Phase]
Measured by using Subject Diaries (Subject Reported Data)
- Number of Spotting Days [Last 90 days in Contraception Phase and first 360 days in HRT Phase]
Measured by using Subject Diaries (Subject Reported Data)
- Percentage of Participants With Successful Treatment [Last 90 days in Contraception Phase and first 360 days in HRT Phase]
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
Secondary Outcome Measures
- 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]
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.
- Continuation Rates [At entry, at 2 years, at 4 years]
Percentage of subjects continuing in the study at the given time points.
- 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]
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
- 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]
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
- 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]
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
- Progestogenic Symptom 4: Nausea (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]
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
- Progestogenic Symptom 5: Edema (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]
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
- Progestogenic Symptom 6: Decreased Libido (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]
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
- Climacteric Symptom 1: Hot Flushes (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]
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
- Climacteric Symptom 2: Sweating Episodes (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]
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
- Climacteric Symptom 3: Vaginal Dryness (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]
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
- Climacteric Symptom 4: Sleep Problems (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]
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
- Climacteric Symptom 5: Irritability (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]
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
- Climacteric Symptom 6: Breast Tension (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]
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
- Progestogenic Symptom 7: Hair Loss (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]
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
- Progestogenic Symptom 8: Greasy Hair (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]
Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.
Eligibility Criteria
Criteria
Ages Eligible for Study:
46 Years
to 51 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gent | Belgium | 9000 | ||
| 2 | HUY | Belgium | 4500 | ||
| 3 | Espoo | Finland | 02100 | ||
| 4 | Turku | Finland | 20100 | ||
| 5 | Turku | Finland | 20520 | ||
| 6 | Heerlen | Netherlands | 6419 PC | ||
| 7 | Venlo | Netherlands | 5912 BL | ||
| 8 | Zaandam | Netherlands | 1502 DV | ||
| 9 | Zwijndrecht | Netherlands | 3331 LZ | ||
| 10 | Cambridge | Cambridgeshire | United Kingdom | CB23 2TN | |
| 11 | Poole | Dorset | United Kingdom | BH15 2JB | |
| 12 | Newcastle upon Tyne | United Kingdom | NE4 6BE |
Sponsors and Collaborators
- Bayer
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT00185458
Other Study ID Numbers:
- 90660
- 300400
First Posted:
Sep 16, 2005
Last Update Posted:
Nov 27, 2013
Last Verified:
Nov 1, 2013
Study Results
Participant Flow
| Recruitment Details | 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 Detail | 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). |
| Arm/Group Title | LNG IUS |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Contraception Phase | |
| STARTED | 394 |
| COMPLETED | 336 |
| NOT COMPLETED | 58 |
| Period Title: Contraception Phase | |
| STARTED | 168 |
| COMPLETED | 141 |
| NOT COMPLETED | 27 |
Baseline Characteristics
| Arm/Group Title | LNG IUS |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 394 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
47.8
(1.42)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
394
100%
|
| Male |
0
0%
|
Outcome Measures
| Title | Number of Bleeding Days |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to treat population (ITT); all subjects with adequate bleeding diary data. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. |
| Arm/Group Title | Reference Period -1 (Contraception Phase) | Reference Period 1 (HRT Phase) | Reference Period 2 (HRT Phase) | Reference Period 3 (HRT Phase) | Reference Period 4 (HRT Phase) |
|---|---|---|---|---|---|
| Arm/Group Description | Patient assessment within the last 90-days before starting the HRT | Patient assessment within the first 90-days of the HRT phase | Patient assessment within day 91 to 180 of the HRT phase | Patient assessment within day 181 to 270 of the HRT phase | Patient assessment within day 271 to 360 of the HRT phase |
| Measure Participants | 165 | 154 | 151 | 141 | 132 |
| Median (Inter-Quartile Range) [Bleeding days] |
0
|
0
|
0
|
0
|
0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Reference Period -1 (Contraception Phase), Reference Period 1 (HRT Phase) |
|---|---|---|
| Comments | Time effect tested with Friedman's two-way analysis of variance (ANOVA). The null-hypothesis is that the means are equal at the reference period tested. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.128 |
| Comments | ||
| Method | Friedman's two-way ANOVA | |
| Comments | ||
| Title | Number of Spotting Days |
|---|---|
| Description | Measured by using Subject Diaries (Subject Reported Data) |
| Time Frame | Last 90 days in Contraception Phase and first 360 days in HRT Phase |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT; all subjects with adequate bleeding diary data. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. |
| Arm/Group Title | Reference Period -1 (Contraception Phase) | Reference Period 1 (HRT Phase) | Reference Period 2 (HRT Phase) | Reference Period 3 (HRT Phase) | Reference Period 4 (HRT Phase) |
|---|---|---|---|---|---|
| Arm/Group Description | Patient assessment within the last 90-days before starting the HRT | Patient assessment within the first 90-days of the HRT phase | Patient assessment within day 91 to 180 of the HRT phase | Patient assessment within day 181 to 270 of the HRT phase | Patient assessment within day 271 to 360 of the HRT phase |
| Measure Participants | 165 | 154 | 151 | 141 | 132 |
| Median (Inter-Quartile Range) [Spotting days] |
4
|
4
|
2
|
1
|
0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Reference Period -1 (Contraception Phase), Reference Period 1 (HRT Phase) |
|---|---|---|
| Comments | Time effect tested with Friedman's two-way analysis of variance (ANOVA). The null-hypothesis is that the means are equal at the reference period tested. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.296 |
| Comments | ||
| Method | Friedman's two-way ANOVA | |
| Comments | ||
| Title | Percentage of Participants With Successful Treatment |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT; all subjects eligible for the HRT |
| Arm/Group Title | LNG IUS |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 168 |
| Number [Percentage of participants with success] |
31
7.9%
|
| Title | Assessment of QOL as Measured by Women's Health Questionnaire |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. |
| Arm/Group Title | Last Measurement Before Start of HRT Phase | 6 Months After Start of HRT Phase | 12 Months After Start of HRT Phase |
|---|---|---|---|
| Arm/Group Description | Patient assessment at the end of contraception phase | Patient assessment about day 180 of the HRT phase | Patient assessment about day 360 of the HRT phase |
| Measure Participants | 165 | 148 | 141 |
| Mean (Standard Deviation) [score on a scale] |
104.1
(17.75)
|
114.4
(16.64)
|
112.9
(16.32)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Reference Period -1 (Contraception Phase), Reference Period 1 (HRT Phase), Reference Period 2 (HRT Phase) |
|---|---|---|
| Comments | This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Friedman's two-way ANOVA | |
| Comments | ||
| Title | Continuation Rates |
|---|---|
| Description | Percentage of subjects continuing in the study at the given time points. |
| Time Frame | At entry, at 2 years, at 4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT. Kaplan-Meier estimator given. |
| Arm/Group Title | LNG IUS |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 394 |
| At Entry |
100.0
25.4%
|
| At 2 Years |
72.3
18.4%
|
| At 4 Years |
23.6
6%
|
| Title | Progestogenic Symptom 1: Headache (as Measured by a Visual Analogue Scale (VAS)) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. |
| Arm/Group Title | Last Measurement Before Start of HRT Phase | 6 Months After Start of HRT Phase | 12 Months After Start of HRT Phase |
|---|---|---|---|
| Arm/Group Description | Patient assessment at the end of contraception phase | Patient assessment about day 180 of the HRT phase | Patient assessment about day 360 of the HRT phase |
| Measure Participants | 168 | 147 | 139 |
| Mean (Standard Deviation) [score on a scale] |
23.9
(23.98)
|
19.1
(22.57)
|
18.2
(23.00)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Reference Period -1 (Contraception Phase), Reference Period 1 (HRT Phase), Reference Period 2 (HRT Phase) |
|---|---|---|
| Comments | This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.027 |
| Comments | ||
| Method | Friedman's two-way ANOVA | |
| Comments | ||
| Title | Progestogenic Symptom 2: Depressive Mood (as Measured by a VAS) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. |
| Arm/Group Title | Last Measurement Before Start of HRT Phase | 6 Months After Start of HRT Phase | 12 Months After Start of HRT Phase |
|---|---|---|---|
| Arm/Group Description | Patient assessment at the end of contraception phase | Patient assessment about day 180 of the HRT phase | Patient assessment about day 360 of the HRT phase |
| Measure Participants | 167 | 147 | 139 |
| Mean (Standard Deviation) [score on a scale] |
22.3
(25.69)
|
11.8
(17.31)
|
14.6
(22.10)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Reference Period -1 (Contraception Phase), Reference Period 1 (HRT Phase), Reference Period 2 (HRT Phase) |
|---|---|---|
| Comments | This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Friedman's two-way ANOVA | |
| Comments | ||
| Title | Progestogenic Symptom 3: Acne or Greasy Skin (as Measured by a VAS) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. |
| Arm/Group Title | Last Measurement Before Start of HRT Phase | 6 Months After Start of HRT Phase | 12 Months After Start of HRT Phase |
|---|---|---|---|
| Arm/Group Description | Patient assessment at the end of contraception phase | Patient assessment about day 180 of the HRT phase | Patient assessment about day 360 of the HRT phase |
| Measure Participants | 168 | 147 | 139 |
| Mean (Standard Deviation) [score on a scale] |
8.9
(14.02)
|
7.3
(15.38)
|
7.6
(15.41)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Reference Period -1 (Contraception Phase), Reference Period 1 (HRT Phase), Reference Period 2 (HRT Phase) |
|---|---|---|
| Comments | This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Friedman's two-way ANOVA | |
| Comments | ||
| Title | Progestogenic Symptom 4: Nausea (as Measured by a VAS) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. |
| Arm/Group Title | Last Measurement Before Start of HRT Phase | 6 Months After Start of HRT Phase | 12 Months After Start of HRT Phase |
|---|---|---|---|
| Arm/Group Description | Patient assessment at the end of contraception phase | Patient assessment about day 180 of the HRT phase | Patient assessment about day 360 of the HRT phase |
| Measure Participants | 168 | 147 | 139 |
| Mean (Standard Deviation) [score on a scale] |
7.5
(13.57)
|
5.3
(11.96)
|
6.7
(15.32)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Reference Period -1 (Contraception Phase), Reference Period 1 (HRT Phase), Reference Period 2 (HRT Phase) |
|---|---|---|
| Comments | This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Friedman's two-way ANOVA | |
| Comments | ||
| Title | Progestogenic Symptom 5: Edema (as Measured by a VAS) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. |
| Arm/Group Title | Last Measurement Before Start of HRT Phase | 6 Months After Start of HRT Phase | 12 Months After Start of HRT Phase |
|---|---|---|---|
| Arm/Group Description | Patient assessment at the end of contraception phase | Patient assessment about day 180 of the HRT phase | Patient assessment about day 360 of the HRT phase |
| Measure Participants | 168 | 147 | 139 |
| Mean (Standard Deviation) [score on a scale] |
15.7
(20.30)
|
12.3
(18.93)
|
11.7
(17.65)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Reference Period -1 (Contraception Phase), Reference Period 1 (HRT Phase), Reference Period 2 (HRT Phase) |
|---|---|---|
| Comments | This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.054 |
| Comments | ||
| Method | Friedman's two-way ANOVA | |
| Comments | ||
| Title | Progestogenic Symptom 6: Decreased Libido (as Measured by a VAS) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. |
| Arm/Group Title | Last Measurement Before Start of HRT Phase | 6 Months After Start of HRT Phase | 12 Months After Start of HRT Phase |
|---|---|---|---|
| Arm/Group Description | Patient assessment at the end of contraception phase | Patient assessment about day 180 of the HRT phase | Patient assessment about day 360 of the HRT phase |
| Measure Participants | 166 | 144 | 135 |
| Mean (Standard Deviation) [score on a scale] |
24.9
(26.29)
|
15.6
(22.06)
|
17.5
(21.13)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Reference Period -1 (Contraception Phase), Reference Period 1 (HRT Phase), Reference Period 2 (HRT Phase) |
|---|---|---|
| Comments | This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Friedman's two-way ANOVA | |
| Comments | ||
| Title | Climacteric Symptom 1: Hot Flushes (as Measured by a VAS) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. |
| Arm/Group Title | Last Measurement Before Start of HRT Phase | 6 Months After Start of HRT Phase | 12 Months After Start of HRT Phase |
|---|---|---|---|
| Arm/Group Description | Patient assessment at the end of contraception phase | Patient assessment about day 180 of the HRT phase | Patient assessment about day 360 of the HRT phase |
| Measure Participants | 167 | 147 | 138 |
| Mean (Standard Deviation) [score on a scale] |
39.9
(30.21)
|
9.4
(14.88)
|
11.3
(18.65)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Reference Period -1 (Contraception Phase), Reference Period 1 (HRT Phase), Reference Period 2 (HRT Phase) |
|---|---|---|
| Comments | This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Friedman's two-way ANOVA | |
| Comments | ||
| Title | Climacteric Symptom 2: Sweating Episodes (as Measured by a VAS) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. |
| Arm/Group Title | Last Measurement Before Start of HRT Phase | 6 Months After Start of HRT Phase | 12 Months After Start of HRT Phase |
|---|---|---|---|
| Arm/Group Description | Patient assessment at the end of contraception phase | Patient assessment about day 180 of the HRT phase | Patient assessment about day 360 of the HRT phase |
| Measure Participants | 167 | 147 | 138 |
| Mean (Standard Deviation) [score on a scale] |
43.0
(29.40)
|
14.0
(19.95)
|
17.0
(21.97)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Reference Period -1 (Contraception Phase), Reference Period 1 (HRT Phase), Reference Period 2 (HRT Phase) |
|---|---|---|
| Comments | This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Friedman's two-way ANOVA | |
| Comments | ||
| Title | Climacteric Symptom 3: Vaginal Dryness (as Measured by a VAS) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. |
| Arm/Group Title | Last Measurement Before Start of HRT Phase | 6 Months After Start of HRT Phase | 12 Months After Start of HRT Phase |
|---|---|---|---|
| Arm/Group Description | Patient assessment at the end of contraception phase | Patient assessment about day 180 of the HRT phase | Patient assessment about day 360 of the HRT phase |
| Measure Participants | 167 | 147 | 138 |
| Mean (Standard Deviation) [score on a scale] |
22.8
(27.96)
|
13.1
(20.93)
|
16.7
(23.00)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Reference Period -1 (Contraception Phase), Reference Period 1 (HRT Phase), Reference Period 2 (HRT Phase) |
|---|---|---|
| Comments | This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Friedman's two-way ANOVA | |
| Comments | ||
| Title | Climacteric Symptom 4: Sleep Problems (as Measured by a VAS) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. |
| Arm/Group Title | Last Measurement Before Start of HRT Phase | 6 Months After Start of HRT Phase | 12 Months After Start of HRT Phase |
|---|---|---|---|
| Arm/Group Description | Patient assessment at the end of contraception phase | Patient assessment about day 180 of the HRT phase | Patient assessment about day 360 of the HRT phase |
| Measure Participants | 167 | 147 | 138 |
| Mean (Standard Deviation) [score on a scale] |
39.4
(29.71)
|
17.1
(21.34)
|
19.9
(23.93)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Reference Period -1 (Contraception Phase), Reference Period 1 (HRT Phase), Reference Period 2 (HRT Phase) |
|---|---|---|
| Comments | This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Friedman's two-way ANOVA | |
| Comments | ||
| Title | Climacteric Symptom 5: Irritability (as Measured by a VAS) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. |
| Arm/Group Title | Last Measurement Before Start of HRT Phase | 6 Months After Start of HRT Phase | 12 Months After Start of HRT Phase |
|---|---|---|---|
| Arm/Group Description | Patient assessment at the end of contraception phase | Patient assessment about day 180 of the HRT phase | Patient assessment about day 360 of the HRT phase |
| Measure Participants | 167 | 147 | 138 |
| Mean (Standard Deviation) [score on a scale] |
33.1
(27.40)
|
17.2
(19.47)
|
19.4
(20.26)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Reference Period -1 (Contraception Phase), Reference Period 1 (HRT Phase), Reference Period 2 (HRT Phase) |
|---|---|---|
| Comments | This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Friedman's two-way ANOVA | |
| Comments | ||
| Title | Climacteric Symptom 6: Breast Tension (as Measured by a VAS) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. |
| Arm/Group Title | Last Measurement Before Start of HRT Phase | 6 Months After Start of HRT Phase | 12 Months After Start of HRT Phase |
|---|---|---|---|
| Arm/Group Description | Patient assessment at the end of contraception phase | Patient assessment about day 180 of the HRT phase | Patient assessment about day 360 of the HRT phase |
| Measure Participants | 167 | 147 | 138 |
| Mean (Standard Deviation) [score on a scale] |
15.5
(22.16)
|
13.5
(20.39)
|
13.0
(19.42)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Reference Period -1 (Contraception Phase), Reference Period 1 (HRT Phase), Reference Period 2 (HRT Phase) |
|---|---|---|
| Comments | This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.175 |
| Comments | ||
| Method | Friedman's two-way ANOVA | |
| Comments | ||
| Title | Progestogenic Symptom 7: Hair Loss (as Measured by a VAS) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. |
| Arm/Group Title | Last Measurement Before Start of HRT Phase | 6 Months After Start of HRT Phase | 12 Months After Start of HRT Phase |
|---|---|---|---|
| Arm/Group Description | Patient assessment at the end of contraception phase | Patient assessment about day 180 of the HRT phase | Patient assessment about day 360 of the HRT phase |
| Measure Participants | 168 | 147 | 139 |
| Mean (Standard Deviation) [score on a scale] |
10.0
(15.14)
|
9.3
(16.69)
|
9.0
(13.63)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Reference Period -1 (Contraception Phase), Reference Period 1 (HRT Phase), Reference Period 2 (HRT Phase) |
|---|---|---|
| Comments | This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.062 |
| Comments | ||
| Method | Friedman's two-way ANOVA | |
| Comments | ||
| Title | Progestogenic Symptom 8: Greasy Hair (as Measured by a VAS) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. |
| Arm/Group Title | Last Measurement Before Start of HRT Phase | 6 Months After Start of HRT Phase | 12 Months After Start of HRT Phase |
|---|---|---|---|
| Arm/Group Description | Patient assessment at the end of contraception phase | Patient assessment about day 180 of the HRT phase | Patient assessment about day 360 of the HRT phase |
| Measure Participants | 168 | 146 | 139 |
| Mean (Standard Deviation) [score on a scale] |
14.0
(20.60)
|
11.5
(18.85)
|
11.1
(18.93)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Reference Period -1 (Contraception Phase), Reference Period 1 (HRT Phase), Reference Period 2 (HRT Phase) |
|---|---|---|
| Comments | This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Friedman's two-way ANOVA | |
| Comments | ||
Adverse Events
| Time Frame | The data covers the entire treatment period (contraception phase + HRT phase). | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | LNG IUS | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| LNG IUS | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| LNG IUS | ||
| Affected / at Risk (%) | # Events | |
| Total | 25/394 (6.3%) | |
| Cardiac disorders | ||
| Palpitations | 1/394 (0.3%) | |
| Gastrointestinal disorders | ||
| Abdominal pain | 1/394 (0.3%) | |
| Crohn's disease | 1/394 (0.3%) | |
| Ileus | 1/394 (0.3%) | |
| Volvulus | 1/394 (0.3%) | |
| Hepatobiliary disorders | ||
| Cholelithiasis | 1/394 (0.3%) | |
| Infections and infestations | ||
| Bronchitis | 1/394 (0.3%) | |
| Pneumonia | 1/394 (0.3%) | |
| Injury, poisoning and procedural complications | ||
| Muscle rupture | 1/394 (0.3%) | |
| Musculoskeletal and connective tissue disorders | ||
| Intervertebral disc protrusion | 1/394 (0.3%) | |
| Periarthritis | 1/394 (0.3%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Breast cancer | 4/394 (1%) | |
| Uterine leiomyoma | 2/394 (0.5%) | |
| Nervous system disorders | ||
| Cerebrovascular accident | 1/394 (0.3%) | |
| Transient ischaemic attack | 1/394 (0.3%) | |
| Renal and urinary disorders | ||
| Bladder prolapse | 1/394 (0.3%) | |
| Reproductive system and breast disorders | ||
| Colpocele | 1/394 (0.3%) | |
| Cystocele | 1/394 (0.3%) | |
| Ovarian cyst | 1/394 (0.3%) | |
| Surgical and medical procedures | ||
| Cholecystectomy | 1/394 (0.3%) | |
| Jejunectomy | 1/394 (0.3%) | |
| Scar excision | 1/394 (0.3%) | |
| Splenectomy | 1/394 (0.3%) | |
| Thyroidectomy | 1/394 (0.3%) | |
| Varicose vein operation | 1/394 (0.3%) | |
| Vascular disorders | ||
| Venous thrombosis limb | 1/394 (0.3%) | |
Other (Not Including Serious) Adverse Events |
||
| LNG IUS | ||
| Affected / at Risk (%) | # Events | |
| Total | 357/394 (90.6%) | |
| Cardiac disorders | ||
| Palpitations | 12/394 (3%) | |
| Gastrointestinal disorders | ||
| Abdominal pain | 30/394 (7.6%) | |
| Abdominal pain lower | 16/394 (4.1%) | |
| Abdominal distension | 12/394 (3%) | |
| Nausea | 9/394 (2.3%) | |
| General disorders | ||
| Fatigue | 14/394 (3.6%) | |
| Infections and infestations | ||
| Influenza | 43/394 (10.9%) | |
| Vaginal candidiasis | 29/394 (7.4%) | |
| Cystitis | 26/394 (6.6%) | |
| Nasopharyngitis | 24/394 (6.1%) | |
| Bronchitis | 20/394 (5.1%) | |
| Sinusitis | 19/394 (4.8%) | |
| Vaginitis bacterial | 15/394 (3.8%) | |
| Vaginal infection | 14/394 (3.6%) | |
| Upper respiratory tract infection | 13/394 (3.3%) | |
| Urinary tract infection | 11/394 (2.8%) | |
| Vulvovaginal mycotic infection | 11/394 (2.8%) | |
| Acute sinusitis | 8/394 (2%) | |
| Respiratory tract infection | 8/394 (2%) | |
| Tooth infection | 8/394 (2%) | |
| Injury, poisoning and procedural complications | ||
| Procedural pain | 117/394 (29.7%) | |
| Investigations | ||
| Smear cervix normal | 31/394 (7.9%) | |
| Weight increased | 17/394 (4.3%) | |
| Musculoskeletal and connective tissue disorders | ||
| Back pain | 47/394 (11.9%) | |
| Pain in extremity | 23/394 (5.8%) | |
| Arthralgia | 20/394 (5.1%) | |
| Musculoskeletal pain | 11/394 (2.8%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Uterine leiomyoma | 26/394 (6.6%) | |
| Nervous system disorders | ||
| Headache | 59/394 (15%) | |
| Migraine | 13/394 (3.3%) | |
| Dizziness | 10/394 (2.5%) | |
| Psychiatric disorders | ||
| Depression | 19/394 (4.8%) | |
| Sleep disorder | 18/394 (4.6%) | |
| Insomnia | 9/394 (2.3%) | |
| Reproductive system and breast disorders | ||
| Menopausal symptoms | 31/394 (7.9%) | |
| Ovarian cyst | 31/394 (7.9%) | |
| Breast pain | 28/394 (7.1%) | |
| Breast tenderness | 27/394 (6.9%) | |
| Genital haemorrhage | 19/394 (4.8%) | |
| Vaginal discharge | 14/394 (3.6%) | |
| Metrorrhagia | 12/394 (3%) | |
| Cervical polyp | 9/394 (2.3%) | |
| Breast cyst | 8/394 (2%) | |
| Vulvovaginal pruritus | 8/394 (2%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 12/394 (3%) | |
| Skin and subcutaneous tissue disorders | ||
| Night sweats | 29/394 (7.4%) | |
| Hyperhidrosis | 27/394 (6.9%) | |
| Acne | 8/394 (2%) | |
| Vascular disorders | ||
| Hypertension | 23/394 (5.8%) | |
| Hot flush | 14/394 (3.6%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The investigators agree to allow the sponsor to review any manuscripts and to negotiate the times and forums of their publication.
Results Point of Contact
| Name/Title | Therapeutic Area Head |
|---|---|
| Organization | BAYER |
| Phone | |
| clinical-trials-contact@bayerhealthcare.com |
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT00185458
Other Study ID Numbers:
- 90660
- 300400
First Posted:
Sep 16, 2005
Last Update Posted:
Nov 27, 2013
Last Verified:
Nov 1, 2013