NCT02218463

Treatment of Prepubertal Labial Adhesions

Treatment of Prepubertal Labial Adhesions: A Prospective Comparison of Topical Emollient Versus Topical Estrogen.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Children's Mercy Hospital Kansas City · Academic / Other
• Sex: Female
• Age: 3 Months – 12 Years
• Healthy volunteers: Not accepted

Summary

First-line treatment for labial adhesions in prepubertal girls has been topical estrogen. This study aims to evaluate an alternative and less costly option of treatment with potentially less side effects. Primary Hypothesis: There will be a difference in complete resolution of labial adhesions with topical estrogen with lateral traction as compared to an emollient with lateral traction.

Detailed description

The etiology of labial adhesions is unclear but appears to be related to hypoestrogenism in combination with vulvar irritation. For many years, first-line treatment for labial adhesions in prepubertal girls has been topical estrogen. With the use of topical estrogen, 50% of labial adhesions resolve in 2 to 3 weeks and most labial adhesions resolve with 6 weeks of treatment. However, because topical estrogen is systemically absorbed, its use is associated with side effects such as breast budding, vulvar hyperpigmentation, vaginal bleeding. There is a high risk of recurrence of labial adhesions of up to 35% after treatment with topical estrogen. In addition, topical estrogen is costly. Therefore, there continues to be controversy over the optimal treatment of labial adhesions in prepubertal girls. Generally, for medical treatment of labial adhesions, topical estrogen is applied to the adhesion whist applying gentle lateral traction to promote separation of the labia. It is, therefore, plausible that the lateral traction applied to the adhesion site is what ultimately results in the separation of the labial fusion, while the use of estrogen improves healing after mechanical separation. This is a single site, prospective, randomized, double-blinded study evaluating the comparative effectiveness of topical estrogen with lateral traction versus topical emollient with lateral traction for the treatment of labial adhesions in prepubertal girls.

Conditions

• Prepubertal Labial Adhesions

Interventions

Type	Name	Description
DRUG	Estradiol cream 0.01%	Apply a pea-sized amount to the labial adhesion with lateral traction twice daily
DRUG	Cetaphil	Apply a pea-sized amount to the labial adhesion with lateral traction twice daily

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2014-08-18
• Last updated: 2025-04-23
• Results posted: 2019-11-27

Locations

1 site across 1 country: United States