Study in Women With Idiopathic Menorrhagia to Determine t... | NCT00360490

ID	Type	Description	Link
309849	Other Identifier	Bayer

Status Module

Label	Type	Description	Intervention Names
Levonorgestrel Intrauterine System (LNG IUS) 20µg per 24 hours	Experimental	Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.	Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
Medroxyprogesterone acetate (MPA)	Active Comparator	Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.	Drug: Medroxyprogesterone acetate

Name	Type	Description	Arm Group Labels	Other Names
Levonorgestrel IUS (Mirena, BAY86-5028)	Drug	Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.	Levonorgestrel Intrauterine System (LNG IUS) 20µg per 24 hours

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)	The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the composite MBL measured during each of the cycles during the Screening Phase. End-of-study MBL was measured during Cycle 6 of the Treatment Phase.	Baseline and up to 6 months
Percentage of Patients With Successful Treatment	End-of-study MBL < 80 mL and a decrease to a value no greater than 50% of the Baseline MBL was considered to be treatment success.	At 6 months

Secondary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline MBL to End of Study MBL (Cycle 6)	The percent change = {(End of Study MBL - Baseline MBL)/Baseline MBL} x 100.	Baseline and up to 6 months
Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

PubMed Identifier	Type	Citation	Retractions
21475963	Result	Endrikat J, Vilos G, Muysers C, Fortier M, Solomayer E, Lukkari-Lax E. The levonorgestrel-releasing intrauterine system provides a reliable, long-term treatment option for women with idiopathic menorrhagia. Arch Gynecol Obstet. 2012 Jan;285(1):117-21. doi: 10.1007/s00404-011-1902-1. Epub 2011 Apr 8.
22959906	Result

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours	Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
FG001	Medroxyprogesterone Acetate (MPA)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)

The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the composite MBL measured during each of the cycles during the Screening Phase. End-of-study MBL was measured during Cycle 6 of the Treatment Phase.

Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.

Posted

Median

Full Range

milliliter (mL)

Baseline and up to 6 months

ID	Title	Description
OG000	Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours	Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
OG001	Medroxyprogesterone Acetate (MPA)	Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

Units	Counts
Participants	OG00079 OG00181

Title

Denominators

Categories

Title	Measurements
	OG000-128.78(-393.6 to 1242.2) OG001-17.7(-271.5 to 78.6)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The null hypothesis: the absolute change from Baseline MBL to End of Study MBL is equal in the LNG IUS group and the MPA group.	Wilcoxon (Mann-Whitney)		<0.001													No	Superiority or Other

Primary

Percentage of Patients With Successful Treatment

End-of-study MBL < 80 mL and a decrease to a value no greater than 50% of the Baseline MBL was considered to be treatment success.

Posted

Number

Percentage of participants

At 6 months

ID	Title	Description
OG000	Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours	Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
OG001	Medroxyprogesterone Acetate (MPA)	Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

Units	Counts
Participants

Secondary

Percent Change From Baseline MBL to End of Study MBL (Cycle 6)

The percent change = {(End of Study MBL - Baseline MBL)/Baseline MBL} x 100.

Posted

Mean

Standard Deviation

Percent change

Baseline and up to 6 months

ID	Title	Description
OG000	Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours	Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
OG001	Medroxyprogesterone Acetate (MPA)	Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

Units	Counts
Participants	OG000

Secondary

Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)

The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Mid-study MBL was measured during Cycle 3 of the Treatment Phase.

Posted

Median

Full Range

milliliter (mL)

Baseline and up to 3 months

ID	Title	Description
OG000	Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours	Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
OG001	Medroxyprogesterone Acetate (MPA)	Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

Units	Counts
Participants

Secondary

Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)

The percent change = {(Mid-study MBL - Baseline MBL)/Baseline MBL} x 100.

Posted

Mean

Standard Deviation

Percent change

Baseline and up to 3 months

ID	Title	Description
OG000	Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours	Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
OG001	Medroxyprogesterone Acetate (MPA)	Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group

Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis.

Posted

Number

percentage of participants

Baseline and up to 6 months

ID	Title	Description
OG000	Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours	Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.

Units	Counts
Participants	OG00079

Secondary

Total Number of Bleeding Days

In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.

Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.

Posted

Mean

Standard Deviation

days

Baseline and up to 6 months

ID	Title	Description
OG000	Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours	Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
OG001	Medroxyprogesterone Acetate (MPA)	Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

Units	Counts
Participants	OG000

Secondary

Total Number of Spotting and Bleeding Days

Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.

Posted

Mean

Standard Deviation

days

Baseline and up to 6 months

ID	Title	Description
OG000	Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours	Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
OG001	Medroxyprogesterone Acetate (MPA)	Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

Units	Counts
Participants	OG000

Secondary

Total Number of Spotting Days

Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.

Posted

Mean

Standard Deviation

days

Baseline and up to 6 months

ID	Title	Description
OG000	Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours	Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
OG001	Medroxyprogesterone Acetate (MPA)	Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

Units	Counts
Participants	OG000

Secondary

Total Number of Bleeding Episodes

A bleeding episode is defined as a light, normal or heavy bleeding, during a minimum of one day. In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.

Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.

Posted

Mean

Standard Deviation

number of bleeding episodes

Baseline and up to 6 months

ID	Title	Description
OG000	Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours	Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
OG001	Medroxyprogesterone Acetate (MPA)	Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

Units	Counts
Participants

Secondary

Percent Change in Hemoglobin

Among of the 165 Full Analysis Set (FAS) subjects, a total of 150 subjects (75 for LNG IUS and 75 for MPA) were available for the analysis.

Posted

Median

Full Range

percent change

Baseline and up to 6 months

ID	Title	Description
OG000	Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours	Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
OG001	Medroxyprogesterone Acetate (MPA)	Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

Units	Counts
Participants	OG000

Secondary

Percent Change in Hematocrit

Among of the 165 Full Analysis Set (FAS) subjects, a total of 150 subjects (75 for LNG IUS and 75 for MPA) were available for the analysis.

Posted

Median

Full Range

percent change

Baseline and up to 6 months

ID	Title	Description
OG000	Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours	Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
OG001	Medroxyprogesterone Acetate (MPA)	Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

Units	Counts
Participants	OG000

Secondary

Percent Change in Serum Ferritin

Among of the 165 Full Analysis Set (FAS) subjects, a total of 148 subjects (75 for LNG IUS and 73 for MPA) were available for the analysis.

Posted

Median

Full Range

percent change

Baseline and up to 6 months

ID	Title	Description
OG000	Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours	Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
OG001	Medroxyprogesterone Acetate (MPA)	Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With Improvement in the Investigator Global Assessment Scale

"Improved" is classified as 'very much improved', 'much improved', or 'improved' and "not improved" is classified as 'no change', 'worse', 'much worse', or 'very much worse'

Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (78 for LNG IUS and 82 for MPA) were available for the analysis.

Posted

Number

percentage

Up to 6 months

ID	Title	Description
OG000	Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours	Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
OG001	Medroxyprogesterone Acetate (MPA)	Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With Improvement in the Patients Overall Assessment Scale

"Improved" is classified as 'very much improved', 'much improved', or 'improved' and "not improved" is classified as 'no change', 'worse', 'much worse', or 'very much worse'.

Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (78 for LNG IUS and 82 for MPA) were available for the analysis.

Posted

Number

percentage

Up to 6 months

ID	Title	Description
OG000	Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours	Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
OG001	Medroxyprogesterone Acetate (MPA)	Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 11.0	Non-systematic Assessment	EG0003 affected82 at risk EG0012 affected83 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 11.0	Non-systematic Assessment	EG0003 affected82 at risk EG0015 affected83 at risk
Flatulence	Gastrointestinal disorders	MedDRA 11.0	Non-systematic Assessment	EG0002 affected82 at risk EG0010 affected83 at risk
Fatique	General disorders	MedDRA 11.0	Non-systematic Assessment	EG0004 affected82 at risk EG0012 affected83 at risk
Irritability	General disorders	MedDRA 11.0	Non-systematic Assessment	EG0002 affected82 at risk EG0010 affected83 at risk
Vaginitis bacterial	Infections and infestations	MedDRA 11.0	Non-systematic Assessment	EG0009 affected82 at risk EG0013 affected83 at risk
Urinary tract infection	Infections and infestations	MedDRA 11.0	Non-systematic Assessment	EG0006 affected82 at risk EG0013 affected83 at risk
Sinusitis	Infections and infestations	MedDRA 11.0	Non-systematic Assessment	EG0005 affected82 at risk EG0014 affected83 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 11.0	Non-systematic Assessment	EG0005 affected82 at risk EG0011 affected83 at risk
Bronchitis	Infections and infestations	MedDRA 11.0	Non-systematic Assessment	EG0002 affected82 at risk EG0011 affected83 at risk
Gastroenteritis	Infections and infestations	MedDRA 11.0	Non-systematic Assessment	EG0002 affected82 at risk EG0011 affected83 at risk
Nasopharyngitis	Infections and infestations	MedDRA 11.0	Non-systematic Assessment	EG0002 affected82 at risk EG0013 affected83 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 11.0	Non-systematic Assessment	EG0002 affected82 at risk EG0010 affected83 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 11.0	Non-systematic Assessment	EG0002 affected82 at risk EG0013 affected83 at risk
IUCD complication	Injury, poisoning and procedural complications	MedDRA 11.0	Non-systematic Assessment	EG0002 affected82 at risk EG0010 affected83 at risk
Intra-uterine contraceptive device expelled	Injury, poisoning and procedural complications	MedDRA 11.0	Non-systematic Assessment	EG0002 affected82 at risk EG0010 affected83 at risk
Weight increased	Investigations	MedDRA 11.0	Non-systematic Assessment	EG0005 affected82 at risk EG0016 affected83 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Non-systematic Assessment	EG0003 affected82 at risk EG0014 affected83 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Non-systematic Assessment	EG0002 affected82 at risk EG0011 affected83 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Non-systematic Assessment	EG0002 affected82 at risk EG0014 affected83 at risk
Headache	Nervous system disorders	MedDRA 11.0	Non-systematic Assessment	EG00013 affected82 at risk EG0019 affected83 at risk
Depression	Psychiatric disorders	MedDRA 11.0	Non-systematic Assessment	EG0002 affected82 at risk EG0011 affected83 at risk
Libido decreased	Psychiatric disorders	MedDRA 11.0	Non-systematic Assessment	EG0002 affected82 at risk EG0013 affected83 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 11.0	Non-systematic Assessment	EG00010 affected82 at risk EG0012 affected83 at risk
Breast tenderness	Reproductive system and breast disorders	MedDRA 11.0	Non-systematic Assessment	EG0004 affected82 at risk EG0013 affected83 at risk
Pelvis pain	Reproductive system and breast disorders	MedDRA 11.0	Non-systematic Assessment	EG0004 affected82 at risk EG0012 affected83 at risk
Breast cyst	Reproductive system and breast disorders	MedDRA 11.0	Non-systematic Assessment	EG0003 affected82 at risk EG0011 affected83 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 11.0	Non-systematic Assessment	EG0003 affected82 at risk EG0011 affected83 at risk
Uterine spasm	Reproductive system and breast disorders	MedDRA 11.0	Non-systematic Assessment	EG0003 affected82 at risk EG0011 affected83 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 11.0	Non-systematic Assessment	EG0002 affected82 at risk EG0010 affected83 at risk
Coital bleeding	Reproductive system and breast disorders	MedDRA 11.0	Non-systematic Assessment	EG0002 affected82 at risk EG0010 affected83 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 11.0	Non-systematic Assessment	EG0002 affected82 at risk EG0013 affected83 at risk
Genital discharge	Reproductive system and breast disorders	MedDRA 11.0	Non-systematic Assessment	EG0002 affected82 at risk EG0010 affected83 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 11.0	Non-systematic Assessment	EG0002 affected82 at risk EG0010 affected83 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA 11.0	Non-systematic Assessment	EG0002 affected82 at risk EG0011 affected83 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Non-systematic Assessment	EG0002 affected82 at risk EG0010 affected83 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 11.0	Non-systematic Assessment	EG0005 affected82 at risk EG0015 affected83 at risk
Hypertension	Vascular disorders	MedDRA 11.0	Non-systematic Assessment	EG0005 affected82 at risk EG0011 affected83 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Tucson	Arizona	85712	United States

ID	Term
D014592	Uterine Hemorrhage
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008599	Menstruation Disturbances

ID	Term
D009644	Norgestrel
D009652	Norpregnenes
D009650	Norpregnanes
D009654	Norsteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D008525	Medroxyprogesterone
D006908	Hydroxyprogesterones
D011374	Progesterone
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes

ID	Title	Description
BG000	Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours	Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
BG001	Medroxyprogesterone Acetate (MPA)	Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours	Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.			1	82	67	82
EG001	Medroxyprogesterone Acetate (MPA)	Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.			0	83	52	83