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

Stanford University

Status: Completed

Conditions: Ovarian Failure, Premature

Treatments: Drug: 17beta Estradiol; Drug: Conjugated estrogens; Drug: 17Beta Estradiol - transdermal; Drug: Progesterone, micronized

Study type: Interventional

Funder types: Other

Identifiers

NCT01023178

SU-10272009-4262

Details and patient eligibility

About

To directly compare the safety (by laboratory evaluation) and efficacy (feminization and growth) of three commonly used estrogen preparations in adolescent patients with ovarian failure, either due to congenital causes (Turner syndrome) or medical therapies. We hypothesize that transdermal estrogen will have equivalent efficacy and a more favorable safety profile in comparison with conventional oral estrogen replacement.

Full description

Treatment with transdermal 17beta(17β) estradiol resulted in higher estradiol levels and more effective feminization compared to oral conjugated equine estrogen but did not result in an otherwise different biochemical profile in this limited number of heterogeneous patients. OBE (oral beta estradiol) and TBE (transdermal beta estradiol) provide safe and effective alternatives to OCEE (oral conjugated equine estrogen) to induce puberty in girls, but larger prospective randomized trials are required.

Enrollment: 20 patients

Sex: Female

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: in whom initiation of estrogen therapy has been recommended due to ovarian failure

• Outpatients
• age >=12 years to 17.99 years old

Exclusion Criteria:

• spontaneous menses
• significant concurrent medical problem including:
• Liver function tests (LFTs) 3 times normal
• clotting disorder
• ongoing cancer treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Vivelle-Dot

Active Comparator group

Description:

17Beta Estradiol - transdermal

Treatment:

Drug: Progesterone, micronized

Drug: 17Beta Estradiol - transdermal

Premarin

Active Comparator group

Description:

Conjugated estrogens

Treatment:

Drug: Progesterone, micronized

Drug: Conjugated estrogens

Estrace

Active Comparator group

Description:

17beta Estradiol

Treatment:

Drug: Progesterone, micronized

Drug: 17beta Estradiol