Trial Outcomes & Findings for Transdermal Estrogen in Older Premenopausal Women With Anorexia Nervosa (NCT NCT02475265)

Last Updated: 2019-07-22

Results Overview

Percent change in lumbar spine bone mineral density after six-months. Lumbar spine bone mineral density measured by dual energy x-ray absorptiometry.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

6 months

Results posted on

2019-07-22

Participant milestones
Measure	Estradiol 0.045mg/Levonorgestrel 0.015mg 6 months of estradiol 0.045mg/levonorgestrel 0.015mg (once weekly patch). estradiol 0.045 mg/levonorgestrel 0.015mg
Overall Study STARTED	11
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	3

Reasons for withdrawal
Measure	Estradiol 0.045mg/Levonorgestrel 0.015mg 6 months of estradiol 0.045mg/levonorgestrel 0.015mg (once weekly patch). estradiol 0.045 mg/levonorgestrel 0.015mg
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	2

Transdermal Estrogen in Older Premenopausal Women With Anorexia Nervosa

Baseline characteristics by cohort
Measure	Estradiol 0.045mg/Levonorgestrel 0.015mg n=11 Participants 6 months of estradiol 0.045mg/levonorgestrel 0.015mg (once weekly patch). estradiol 0.045 mg/levonorgestrel 0.015mg
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	37.2 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants
Lumbar spine bone mineral density	0.776 g/cm^2 STANDARD_DEVIATION 0.104 • n=5 Participants

Timeframe: 6 months

Percent change in lumbar spine bone mineral density after six-months. Lumbar spine bone mineral density measured by dual energy x-ray absorptiometry.

Outcome measures
Measure	Estradiol 0.045mg/Levonorgestrel 0.015mg n=8 Participants 6 months of estradiol 0.045mg/levonorgestrel 0.015mg (once weekly patch). estradiol 0.045 mg/levonorgestrel 0.015mg
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine by Dual Energy X-ray Absorptiometry (DXA)	2.0 percent change Standard Error 0.8

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Estradiol 0.045mg/Levonorgestrel 0.015mg n=11 participants at risk 6 months of estradiol 0.045mg/levonorgestrel 0.015mg (once weekly patch). estradiol 0.045 mg/levonorgestrel 0.015mg
Gastrointestinal disorders Nausea	27.3% 3/11 • 6 months
Reproductive system and breast disorders Breast tenderness	9.1% 1/11 • 6 months
Skin and subcutaneous tissue disorders Patch site irritation	27.3% 3/11 • 6 months
Gastrointestinal disorders Vomiting	9.1% 1/11 • 6 months

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