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Comparison of Transdermal and Oral Estrogens in Adolescent Girls With Ovarian Failure

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ClinicalTrials.gov Identifier: NCT01023178
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : January 20, 2017
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
Darrell M Wilson, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovarian Failure, Premature
Interventions Drug: 17beta Estradiol
Drug: Conjugated estrogens
Drug: 17Beta Estradiol - transdermal
Drug: Progesterone, micronized
Enrollment 20
Recruitment Details from 2007-2011 study participants were recruited from pediatric endocrinology clinics at Lucile Packard Children's Hospital at Stanford.
Pre-assignment Details  
Arm/Group Title Transdermal 17Beta Estradiol Oral Conjugated Equine Estrogen Oral 17beta Estradiol
Hide Arm/Group Description

17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months

Progesterone, micronized: Given starting at 18 months

Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months

Progesterone, micronized: Given starting at 18 months

17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.

Progesterone, micronized: Given starting at 18 months

Period Title: Overall Study
Started 5 8 7
Completed 3 6 4
Not Completed 2 2 3
Arm/Group Title Transdermal 17Beta Estradiol Oral Conjugated Equine Estrogen Oral 17beta Estradiol Total
Hide Arm/Group Description

17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months

Progesterone, micronized: Given starting at 18 months

Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months

Progesterone, micronized: Given starting at 18 months

17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.

Progesterone, micronized: Given starting at 18 months

Total of all reporting groups
Overall Number of Baseline Participants 5 8 7 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 8 participants 7 participants 20 participants
14.2  (0.5) 13.8  (0.4) 14.5  (0.6) 14.2  (0.6)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Female Number Analyzed 5 participants 8 participants 7 participants 20 participants
5 8 7 20
Follicle Stimulating Hormone (FSH)  
Mean (Full Range)
Unit of measure:  mIU/mL
Number Analyzed 5 participants 8 participants 7 participants 20 participants
76
(1.5 to 144)
86
(0.027 to 197)
71
(0.656 to 144)
78
(0.027 to 197)
Luteinizing Hormone (LH)  
Mean (Full Range)
Unit of measure:  mIU/mL
Number Analyzed 5 participants 8 participants 7 participants 20 participants
14
(0.15 to 26)
26
(0.009 to 86)
13
(0.041 to 26)
18
(0.009 to 86)
1.Primary Outcome
Title Estradiol
Hide Description Estradiol blood levels at end of study compared across groups to determine effect of dosing methods. Significance of levels depends on the stage of puberty and goals of therapy.
Time Frame end of study (up to 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transdermal 17Beta Estradiol Oral Conjugated Equine Estrogen Oral 17beta Estradiol
Hide Arm/Group Description:

17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months

Progesterone, micronized: Given starting at 18 months

Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months

Progesterone, micronized: Given starting at 18 months

17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.

Progesterone, micronized: Given starting at 18 months

Overall Number of Participants Analyzed 3 6 4
Mean (Standard Error)
Unit of Measure: pg/mL
53  (19) 14  (5) 12  (5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Transdermal 17Beta Estradiol Oral Conjugated Equine Estrogen Oral 17beta Estradiol
Hide Arm/Group Description

17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months

Progesterone, micronized: Given starting at 18 months

Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months

Progesterone, micronized: Given starting at 18 months

17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.

Progesterone, micronized: Given starting at 18 months

All-Cause Mortality
Transdermal 17Beta Estradiol Oral Conjugated Equine Estrogen Oral 17beta Estradiol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Transdermal 17Beta Estradiol Oral Conjugated Equine Estrogen Oral 17beta Estradiol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/8 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Transdermal 17Beta Estradiol Oral Conjugated Equine Estrogen Oral 17beta Estradiol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/8 (0.00%)   0/7 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Sejal Shah MD
Organization: Stanford University
Phone: 6507235791
Responsible Party: Darrell M Wilson, Stanford University
ClinicalTrials.gov Identifier: NCT01023178     History of Changes
Other Study ID Numbers: SU-10272009-4262
First Submitted: November 30, 2009
First Posted: December 2, 2009
Results First Submitted: July 16, 2014
Results First Posted: January 20, 2017
Last Update Posted: January 20, 2017