Trial Outcomes & Findings for Study of Lupron Depot In The Treatment of Central Precocious Puberty (NCT NCT00660010)

Last Updated: 2011-04-12

Results Overview

Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of breast development in females. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of breasts. The final visit occurred at a mean age +/- SD of 11.05 +/- 1.14 years (range, 6.96 to 12.95 years).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

55 participants

Primary outcome timeframe

Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

Results posted on

2011-04-12

Participant Flow

This study included 1 treatment group and subjects were assigned the initial dosage depending on their weight. The minimum starting dose was 7.5 mg every 28 days. Study drug was discontinued either when puberty occurred at 12 years +- 6 months for males and 11 years +- 6 months for females or at the discretion of the investigator.

Participant milestones

Participant milestones
Measure	Leuprolide Acetate 1 Month Depot Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
Overall Study STARTED	55
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Leuprolide Acetate 1 Month Depot Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	3
Overall Study Adverse Event	1
Overall Study Noncompliance with visit schedule	3

Baseline Characteristics

Study of Lupron Depot In The Treatment of Central Precocious Puberty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Leuprolide Acetate 1 Month Depot n=55 Participants Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
Age, Categorical <=18 years	55 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age Continuous	6.9 years STANDARD_DEVIATION 1.86 • n=99 Participants
Sex: Female, Male Female	49 Participants n=99 Participants
Sex: Female, Male Male	6 Participants n=99 Participants
Region of Enrollment United States	55 subjects n=99 Participants

PRIMARY outcome

Timeframe: Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

Population: The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. The starting population comprised 49 females (breast development suppression). Study drug was discontinued at the initiation of puberty.

Outcome measures

Outcome measures
Measure	Leuprolide Acetate 1 Month Depot n=49 Participants Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) Breast development suppression - Week 4 N=44	81.8 Percentage of subjects
Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) Breast development suppression-Week 48 N=47	80.9 Percentage of subjects Interval 66.7 to 90.9
Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) Breast development suppression -Week 96 N=41	87.8 Percentage of subjects Interval 73.8 to 95.9
Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) Breast development suppression-Week 144 N=29	82.8 Percentage of subjects Interval 64.2 to 94.2
Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) Breast development suppression - Week 192 N=18	66.7 Percentage of subjects Interval 41.0 to 86.7
Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) Breast development suppression -Week 240 N=13	76.9 Percentage of subjects Interval 46.2 to 95.0
Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females) Breast development suppression-Final Visit N=48	77.1 Percentage of subjects

PRIMARY outcome

Timeframe: Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

Population: The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. The starting population comprised 6 males (genital development suppression). Study drug was discontinued at the initiation of puberty.

Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of genital development in males. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of genitals. The final visit occurred at a mean age +/- SD of 12.35 +/-1.35 years (range, 10.71 to 14.07 years).

Outcome measures

Outcome measures
Measure	Leuprolide Acetate 1 Month Depot n=6 Participants Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males) Genital development suppression - Week 4 N=5	80.0 Percentage of subjects
Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males) Genital development suppression - Week 48 N=6	83.3 Percentage of subjects
Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males) Genital development suppression - Week 96 N=6	83.3 Percentage of subjects
Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males) Genital development suppression - Week 144 N=4	75.0 Percentage of subjects
Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males) Genital development suppression - Week 192 N=4	75.0 Percentage of subjects
Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males) Genital development suppression - Week 240 N=3	66.7 Percentage of subjects
Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males) Genital development suppression - Final Visit N=6	83.3 Percentage of subjects

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

Population: The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. The starting population comprised 49 females and 6 males. Study drug was discontinued at the initiation of puberty.

Mean peak stimulated visit LH and FSH concentrations were assessed according to the DELFIA (registered trademark) assay. The final visit for measurement of both hormone concentrations occurred at a mean age +/- SD of 11.13 +/- 1.23 (range, 6.73 to 14.07) years.

Outcome measures

Outcome measures
Measure	Leuprolide Acetate 1 Month Depot n=55 Participants Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations Peak stimulated LH at Week 12 N = 54	1.1 mIU/mL Standard Deviation 1.77
Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations Peak stimulated LH at Week 24 N = 53	0.8 mIU/mL Standard Deviation 0.79
Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations Peak stimulated LH at Week 48 N = 54	0.6 mIU/mL Standard Deviation 0.47
Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations Peak stimulated LH at Week 96 N = 46	0.4 mIU/mL Standard Deviation 0.33
Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations Peak stimulated LH at Week 144 N = 36	0.4 mIU/mL Standard Deviation 0.24
Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations Peak stimulated LH at Week 192 N = 20	0.4 mIU/mL Standard Deviation 0.25
Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations Peak stimulated LH at Week 240 N = 17	0.4 mIU/mL Standard Deviation 0.62
Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations Peak stimulated LH at Final Visit N = 55	0.8 mIU/mL Standard Deviation 3.29
Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations Peak stimulated FSH at Baseline N=55	13.3 mIU/mL Standard Deviation 5.58
Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations Peak stimulated FSH at Week 4 N = 55	0.9 mIU/mL Standard Deviation 0.44
Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations Peak stimulated FSH at Week 12 N = 54	1.1 mIU/mL Standard Deviation 0.61
Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations Peak stimulated FSH at Week 24 N = 53	1.2 mIU/mL Standard Deviation 0.84
Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations Peak stimulated FSH at Week 96 N = 46	1.4 mIU/mL Standard Deviation 0.79
Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations Peak stimulated FSH at Week 144 N = 36	1.4 mIU/mL Standard Deviation 0.73
Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations Peak stimulated FSH at Week 192 N = 20	1.3 mIU/mL Standard Deviation 0.76
Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations Peak stimulated FSH at Week 240 N = 17	1.4 mIU/mL Standard Deviation 0.67
Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations Peak stimulated FSH at Final Visit N = 55	1.7 mIU/mL Standard Deviation 1.73
Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations Peak stimulated FSH at Week 48 N = 54	1.2 mIU/mL Standard Deviation 0.58
Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations Peak stimulated LH at Baseline N=55	35.0 mIU/mL Standard Deviation 21.32
Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations Peak stimulated LH at Week 4 N = 55	0.8 mIU/mL Standard Deviation 0.57

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

Population: All females in the intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. Study drug was discontinued at the initiation of puberty.

Mean estradiol concentrations were assessed according to the DELFIA (registered trademark) assay. The lower limit of quantitation for estradiol is 5 pg/mL and measurements below this limit are given a value of 5 pg/mL. The final visit for measurement estradiol concentrations occurred at a mean age +/- SD of 10.93 +/- 1.27 (range, 5.59 to 13.24) years.

Outcome measures

Outcome measures
Measure	Leuprolide Acetate 1 Month Depot n=49 Participants Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
Mean Stimulated Estradiol Concentrations in Females Mean stimulated estradiol at baseline N=49	15.3 pg/mL Standard Error 18.73
Mean Stimulated Estradiol Concentrations in Females Mean stimulated estradiol at Week 4 N=48	5.0 pg/mL Standard Error 0.00
Mean Stimulated Estradiol Concentrations in Females Mean stimulated estradiol at Week 12 N=47	6.0 pg/mL Standard Error 6.56
Mean Stimulated Estradiol Concentrations in Females Mean stimulated estradiol at Week 24 N=47	5.0 pg/mL Standard Error 0.00
Mean Stimulated Estradiol Concentrations in Females Mean stimulated estradiol at Week 48 N=47	5.0 pg/mL Standard Error 0.00
Mean Stimulated Estradiol Concentrations in Females Mean stimulated estradiol at Week 96 N=39	5.0 pg/mL Standard Error 0.00
Mean Stimulated Estradiol Concentrations in Females Mean stimulated estradiol at Week 144 N=31	5.0 pg/mL Standard Error 0.00
Mean Stimulated Estradiol Concentrations in Females Mean stimulated estradiol at Week 192 N=15	5.0 pg/mL Standard Error 0.00
Mean Stimulated Estradiol Concentrations in Females Mean stimulated estradiol at Week 240 N=13	5.0 pg/mL Standard Error 0.00
Mean Stimulated Estradiol Concentrations in Females Mean stimulated estradiol at Final Visit N=49	5.0 pg/mL Standard Error 0.14

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

Population: All males in the intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. Study drug was discontinued at the initiation of puberty.

Mean stimulated testosterone concentrations were assessed according to the DELFIA (registered trademark) assay. The final visit for measurement of testosterone occurred at a mean age +/- SD of 12.34 +/- 1.16 (range, 11.14 to 14.07) years.

Outcome measures

Outcome measures
Measure	Leuprolide Acetate 1 Month Depot n=6 Participants Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
Mean Stimulated Testosterone Concentrations in Males Mean stimulated testosterone at baseline N=6	347.7 ng/dL Standard Deviation 121.86
Mean Stimulated Testosterone Concentrations in Males Mean stimulated testosterone at Week 4 N=6	18.0 ng/dL Standard Deviation 12.39
Mean Stimulated Testosterone Concentrations in Males Mean stimulated testosterone at Week 12 N=6	14.2 ng/dL Standard Deviation 7.05
Mean Stimulated Testosterone Concentrations in Males Mean stimulated testosterone at Week 24 N=6	13.8 ng/dL Standard Deviation 6.15
Mean Stimulated Testosterone Concentrations in Males Mean stimulated testosterone at Week 48 N=6	17.3 ng/dL Standard Deviation 11.64
Mean Stimulated Testosterone Concentrations in Males Mean stimulated testosterone at Week 96 N=6	24.8 ng/dL Standard Deviation 19.92
Mean Stimulated Testosterone Concentrations in Males Mean stimulated testosterone at Week 144 N=5	21.6 ng/dL Standard Deviation 19.50
Mean Stimulated Testosterone Concentrations in Males Mean stimulated testosterone at Week 192 N=4	24.0 ng/dL Standard Deviation 17.19
Mean Stimulated Testosterone Concentrations in Males Mean stimulated testosterone at Week 240 N=3	25.3 ng/dL Standard Deviation 24.01
Mean Stimulated Testosterone Concentrations in Males Mean stimulated testosterone at Final Visit N=6	24.2 ng/dL Standard Deviation 17.16

SECONDARY outcome

Timeframe: Week 24 and Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit

Population: The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. Study drug was discontinued at the initiation of puberty.

Bone age was determined by radiography of the wrist according to the Fels Method. The mean ratio of bone age to chronological age provides information about the slowing of bone age progression. A score = 1 indicates that bone age is equal to chronological age.

Outcome measures

Outcome measures
Measure	Leuprolide Acetate 1 Month Depot n=53 Participants Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
Mean Ratio of Bone Age to Chronological Age Ratio at Baseline N=53	1.5 ratio Standard Deviation 0.30
Mean Ratio of Bone Age to Chronological Age Ratio at Week 24 N=53	1.5 ratio Standard Deviation 0.25
Mean Ratio of Bone Age to Chronological Age Ratio at Week 48 N=51	1.4 ratio Standard Deviation 0.18
Mean Ratio of Bone Age to Chronological Age Ratio at Week 96 N=44	1.3 ratio Standard Deviation 0.15
Mean Ratio of Bone Age to Chronological Age Ratio at Week 144 N=31	1.2 ratio Standard Deviation 0.12
Mean Ratio of Bone Age to Chronological Age Ratio at Week 192 N=26	1.2 ratio Standard Deviation 0.11
Mean Ratio of Bone Age to Chronological Age Ratio at Week 240 N=16	1.2 ratio Standard Deviation 0.10
Mean Ratio of Bone Age to Chronological Age Ratio at Final Visit N=53	1.2 ratio Standard Deviation 0.11

OTHER_PRE_SPECIFIED outcome

Timeframe: Final ht. (measured or provided for final questionnaire in subjects >= 18 years of age) or near final adult ht. (<1 cm/year or bone age > 14 years for females or > 15 years for males)

Population: For the follow-up posttreatment period, the ITT population=40 subjects and the safety population=55 subjects who received at least 1 injection of study drug during the treatment period. Study drug was discontinued at the initiation of puberty. The mean age of subjects at final questionnaire completion was 24.76 years with a range of 18.87 to 26.66.

Height was measured by stadiometer and was standardized for age according to standard growth charts. A standardized score of 0 indicated a mean ht. equivalent to mean of a standard population from 2000 CDC standardized ht. charts. Height gain was calculated as ht. - predicted ht. from the Bayley-Pinneau method on the basis of bone age at baseline. Final adult ht. was determined by measurement at final adult ht., if available, or by ht. collected during the follow-up period associated with a growth velocity \<1 cm/year or a bone age \>14 yrs in females or \>15 yrs in males.

Outcome measures

Outcome measures
Measure	Leuprolide Acetate 1 Month Depot n=40 Participants Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
Posttreatment Height (ht.) Compared to Standard Population and as Predicted From Ht. at Baseline (BL) Near final adult ht. standardized score N=33	-0.2 cm Standard Error 1.20
Posttreatment Height (ht.) Compared to Standard Population and as Predicted From Ht. at Baseline (BL) Near final ht.gain from predicted ht. at BL N=29	3.2 cm Standard Error 5.37
Posttreatment Height (ht.) Compared to Standard Population and as Predicted From Ht. at Baseline (BL) Final adult ht.standardized score N=19	0.0 cm Standard Error 1.13
Posttreatment Height (ht.) Compared to Standard Population and as Predicted From Ht. at Baseline (BL) Final adult ht.gain from predicted ht. at BL N=17	3.9 cm Standard Error 5.05

OTHER_PRE_SPECIFIED outcome

Timeframe: Posttreatment during the follow-up period (subjects observed every 6 months until physical and laboratory observations are at pubertal levels)

Population: During the posttreatment period, data were obtained from 32 female subjects. Twenty-seven subjects reported the start of menses, but only 26 subjects reported a menses start date.

Regular menses was defined as 3 or more consecutive days of menstrual-like bleeding and was defined by the investigator's clinical judgment.

Outcome measures

Outcome measures
Measure	Leuprolide Acetate 1 Month Depot n=26 Participants Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
Mean Time to or Mean Age at Regular Menses in Females After Treatment Time to regular menses	1.5 years Standard Deviation 0.53
Mean Time to or Mean Age at Regular Menses in Females After Treatment Age at regular menses	12.9 years Standard Deviation 0.89

OTHER_PRE_SPECIFIED outcome

Timeframe: Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age)

Population: A long-term follow-up questionnaire was sent to all subjects who completed at least 1 visit in the posttreatment follow-up period or who discontinued treatment because they entered puberty naturally at the appropriate age. Twenty female subjects (mean age 24.76 years, range 18.87 to 26.66 years) and 0 male subjects completed the questionnaire.

Subjects were required to complete final adult questionnaire to provide information on adult reproductive function. Regular menses was defined as 3 or more consecutive days of menstrual-like bleeding.

Outcome measures

Outcome measures
Measure	Leuprolide Acetate 1 Month Depot n=20 Participants Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
Number of Female Subjects Who Reported Regular Menses at Adulthood No. of subjects with regular menses as adults	16 Subjects
Number of Female Subjects Who Reported Regular Menses at Adulthood No. of subjects without regular menses as adults	4 Subjects

OTHER_PRE_SPECIFIED outcome

Timeframe: Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age)

The final questionnaire was completed by 20 females who were at least 18 years of age. The subjects reported on total number of pregnancies resulting in live births or number of miscarriages (spontaneous or elective) and whether the subject was currently pregnant.

Outcome measures

Outcome measures
Measure	Leuprolide Acetate 1 Month Depot n=20 Participants Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
Number of Subjects Who Reported Pregnancies at Final Questionnaire Number of subjects who reported being pregnant	7 Subjects
Number of Subjects Who Reported Pregnancies at Final Questionnaire Number of subjects who were currently pregnant	1 Subjects

OTHER_PRE_SPECIFIED outcome

Timeframe: Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age)

The final questionnaire was completed by 20 female subjects who were at least 18 years of age. The total number of pregnancies were reported.

Outcome measures

Outcome measures
Measure	Leuprolide Acetate 1 Month Depot n=20 Participants Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
Number of Pregnancies Reported by Subjects at Final Questionnaire Number of pregnancies	12 Pregnancies
Number of Pregnancies Reported by Subjects at Final Questionnaire Number of live births	6 Pregnancies
Number of Pregnancies Reported by Subjects at Final Questionnaire Number of miscarriages	5 Pregnancies

Adverse Events

Leuprolide Acetate 1 Month Depot

Serious events: 7 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Leuprolide Acetate 1 Month Depot n=55 participants at risk Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
General disorders Aggravation reaction	1.8% 1/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma	1.8% 1/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Infections and infestations Infection	1.8% 1/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Cardiac disorders Heart arrest	1.8% 1/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Musculoskeletal and connective tissue disorders Bone Disorder	1.8% 1/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Musculoskeletal and connective tissue disorders Pathological fracture	1.8% 1/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Psychiatric disorders Personality disorder	1.8% 1/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Respiratory, thoracic and mediastinal disorders Asthma	1.8% 1/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Infections and infestations Pneumonia	1.8% 1/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Surgical and medical procedures Repair of ventriculoperitoneal shunt	1.8% 1/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.

Other adverse events

Other adverse events
Measure	Leuprolide Acetate 1 Month Depot n=55 participants at risk Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
Gastrointestinal disorders Abdominal pain	29.1% 16/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Injury, poisoning and procedural complications Accidental injury	29.1% 16/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Immune system disorders Allergic reaction	10.9% 6/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
General disorders Asthenia	10.9% 6/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Skin and subcutaneous tissue disorders Body odor	5.5% 3/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
General disorders Fever	25.5% 14/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Infections and infestations Flu syndrome	34.5% 19/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Nervous system disorders Headache	45.5% 25/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Infections and infestations Infection	23.6% 13/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
General disorders Injection site pain	14.5% 8/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
General disorders Injection site reaction	5.5% 3/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
General disorders Pain	21.8% 12/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
General disorders Reaction unevaluable	9.1% 5/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Vascular disorders Vasodilatation	10.9% 6/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Gastrointestinal disorders Diarrhea	16.4% 9/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Gastrointestinal disorders Dyspepsia	9.1% 5/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Metabolism and nutrition disorders Increased appetite	9.1% 5/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Gastrointestinal disorders Nausea	12.7% 7/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Gastrointestinal disorders Vomiting	23.6% 13/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Blood and lymphatic system disorders Lymphadenopathy	5.5% 3/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
General disorders Edema	7.3% 4/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Musculoskeletal and connective tissue disorders Growth retarded	10.9% 6/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Investigations Weight gain	16.4% 9/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Investigations Weight loss	5.5% 3/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	5.5% 3/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Musculoskeletal and connective tissue disorders Myalgia	7.3% 4/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Musculoskeletal and connective tissue disorders Pathological fracture	7.3% 4/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Psychiatric disorders Depression	5.5% 3/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Nervous system disorders Dizziness	7.3% 4/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Psychiatric disorders Emotional Lability	27.3% 15/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Psychiatric disorders Nervousness	7.3% 4/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Respiratory, thoracic and mediastinal disorders Cough increased	30.9% 17/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Respiratory, thoracic and mediastinal disorders Epistaxis	10.9% 6/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Infections and infestations Pharyngitis	52.7% 29/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Infections and infestations Rhinitis	25.5% 14/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Infections and infestations Sinusitis	20.0% 11/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Skin and subcutaneous tissue disorders Acne	27.3% 15/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Infections and infestations Herpes zoster	14.5% 8/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Skin and subcutaneous tissue disorders Hirsutism	5.5% 3/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Skin and subcutaneous tissue disorders Pruritus	5.5% 3/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Skin and subcutaneous tissue disorders Rash	32.7% 18/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Skin and subcutaneous tissue disorders Skin disorder	10.9% 6/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Skin and subcutaneous tissue disorders Urticaria	7.3% 4/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Ear and labyrinth disorders Ear pain	7.3% 4/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Eye disorders Eye disorder	5.5% 3/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Infections and infestations Otitis media	27.3% 15/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Reproductive system and breast disorders Leukorrhea	7.3% 4/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Reproductive system and breast disorders Menstrual disorder	5.5% 3/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Infections and infestations Urinary tract infection	7.3% 4/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.
Infections and infestations Vaginitis	20.0% 11/55 • Each investigator monitored each subject for clinical and laboratory evidence of adverse events at Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until the study drug was discontinued. Adverse events were reported from onset after the first injection of study drug through 30 days after treatment was completed. Treatment completion was defined as 28 days after the final study drug injection. The posttreatment follow-up period did not require the reporting of adverse events.

Additional Information

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Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
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