Trial Outcomes & Findings for The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial (NCT NCT00474851)
NCT ID: NCT00474851
Last Updated: 2015-03-30
Results Overview
Adjusted mean change in total body areal bone mineral density (aBMD) over the 12 month trial
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
Baseline to 12 months
Results posted on
2015-03-30
Participant Flow
Participant milestones
| Measure |
Intervention Group
Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily
Norethindrone acetate: Norethindrone acetate 5 mg PO daily
|
Placebo Group
Placebo group
Placebo: Placebo capsule 1 pill PO daily
Norethindrone acetate: Norethindrone acetate 5 mg PO daily
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
27
|
|
Overall Study
Completed Baseline
|
25
|
26
|
|
Overall Study
COMPLETED
|
18
|
16
|
|
Overall Study
NOT COMPLETED
|
8
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial
Baseline characteristics by cohort
| Measure |
Intervention Group
n=25 Participants
Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily
Norethindrone acetate: Norethindrone acetate 5 mg PO daily
|
Placebo Group
n=26 Participants
Placebo: Placebo capsule 1 pill PO daily
Norethindrone acetate: Norethindrone acetate 5 mg PO daily
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
17.7 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
18.1 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
17.9 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
51 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsAdjusted mean change in total body areal bone mineral density (aBMD) over the 12 month trial
Outcome measures
| Measure |
Intervention Group
n=25 Participants
Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily
Norethindrone acetate: Norethindrone acetate 5 mg PO daily
|
Placebo Group
n=26 Participants
Placebo group
Placebo: Placebo capsule 1 pill PO daily
Norethindrone acetate: Norethindrone acetate 5 mg PO daily
|
|---|---|---|
|
Bone Mineral Density
|
0.01 g/cm^2
Standard Error 0.006
|
-0.11 g/cm^2
Standard Error 0.006
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsOutcome measures
| Measure |
Intervention Group
n=25 Participants
Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily
Norethindrone acetate: Norethindrone acetate 5 mg PO daily
|
Placebo Group
n=26 Participants
Placebo group
Placebo: Placebo capsule 1 pill PO daily
Norethindrone acetate: Norethindrone acetate 5 mg PO daily
|
|---|---|---|
|
Total Body Bone Mineral Content (BMC)
|
37 g
Standard Error 10
|
15 g
Standard Error 11
|
Adverse Events
Intervention Group
Serious events: 8 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo Group
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention Group
n=25 participants at risk
Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily
Norethindrone acetate: Norethindrone acetate 5 mg PO daily
|
Placebo Group
n=26 participants at risk
Placebo group
Placebo: Placebo capsule 1 pill PO daily
Norethindrone acetate: Norethindrone acetate 5 mg PO daily
|
|---|---|---|
|
Reproductive system and breast disorders
Hospitalization for pelvic/abdominal pain
|
12.0%
3/25 • Number of events 4 • Adverse events were evaluated every 3 months (at every research visit) for a total of 12 months (the duration of study participation).
|
0.00%
0/26 • Adverse events were evaluated every 3 months (at every research visit) for a total of 12 months (the duration of study participation).
|
|
Gastrointestinal disorders
Rectal bleeding
|
4.0%
1/25 • Number of events 1 • Adverse events were evaluated every 3 months (at every research visit) for a total of 12 months (the duration of study participation).
|
0.00%
0/26 • Adverse events were evaluated every 3 months (at every research visit) for a total of 12 months (the duration of study participation).
|
|
Psychiatric disorders
Depression
|
4.0%
1/25 • Number of events 1 • Adverse events were evaluated every 3 months (at every research visit) for a total of 12 months (the duration of study participation).
|
19.2%
5/26 • Number of events 7 • Adverse events were evaluated every 3 months (at every research visit) for a total of 12 months (the duration of study participation).
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
12.0%
3/25 • Number of events 3 • Adverse events were evaluated every 3 months (at every research visit) for a total of 12 months (the duration of study participation).
|
0.00%
0/26 • Adverse events were evaluated every 3 months (at every research visit) for a total of 12 months (the duration of study participation).
|
Other adverse events
| Measure |
Intervention Group
n=25 participants at risk
Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily
Norethindrone acetate: Norethindrone acetate 5 mg PO daily
|
Placebo Group
n=26 participants at risk
Placebo group
Placebo: Placebo capsule 1 pill PO daily
Norethindrone acetate: Norethindrone acetate 5 mg PO daily
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Myalgias/arthralgias
|
8.0%
2/25 • Number of events 2 • Adverse events were evaluated every 3 months (at every research visit) for a total of 12 months (the duration of study participation).
|
7.7%
2/26 • Number of events 2 • Adverse events were evaluated every 3 months (at every research visit) for a total of 12 months (the duration of study participation).
|
|
Reproductive system and breast disorders
Pelvic pain
|
32.0%
8/25 • Number of events 11 • Adverse events were evaluated every 3 months (at every research visit) for a total of 12 months (the duration of study participation).
|
30.8%
8/26 • Number of events 8 • Adverse events were evaluated every 3 months (at every research visit) for a total of 12 months (the duration of study participation).
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
12.0%
3/25 • Number of events 3 • Adverse events were evaluated every 3 months (at every research visit) for a total of 12 months (the duration of study participation).
|
7.7%
2/26 • Number of events 2 • Adverse events were evaluated every 3 months (at every research visit) for a total of 12 months (the duration of study participation).
|
|
Psychiatric disorders
Mood swings
|
8.0%
2/25 • Number of events 2 • Adverse events were evaluated every 3 months (at every research visit) for a total of 12 months (the duration of study participation).
|
3.8%
1/26 • Number of events 1 • Adverse events were evaluated every 3 months (at every research visit) for a total of 12 months (the duration of study participation).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place