Pooled analysis of menstrual irregularities from three major clinical studies evaluating everolimus for the treatment of tuberous sclerosis complex.

ABSTRACT:

Objectives

To determine the impact of everolimus on female fertility, including menstrual irregularities, secondary amenorrhea, and luteinizing and follicle stimulating hormone levels in female patients.

Design

A pooled analysis from 3 prospective studies consisting of a core phase (≥6 months) and a long-term follow-up open-label extension.

Setting

One phase 2 single-center and two phase 3 multicenter studies.

Participants

Data were obtained from female participants, restricted to those between 10 and 55 years of age, during 1 of 3 of the described clinical trials of everolimus. Patients had received ≥ 1 dose of everolimus.

Main outcome measures

Incidence of fertility events.

Results

A total of 43/112 patients (38.4%) experienced at least 1 menstr

SUBMITTER: Sparagana S 

PROVIDER: S-EPMC5638404 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature