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Study of GL701 in Men With Systemic Lupus Erythematosus

2014-07-23 21:55:02 | BioPortfolio

Summary

Lupus flares and other symptoms associated with systemic lupus erythematosus (SLE) may be caused by a deficiency of dehydroepiandrosterone (DHEA). GL701 is an investigational new drug meant to enhance DHEA levels. This study is designed to evaluate both the safety and efficacy of GL701 in male lupus patients.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Systemic Lupus Erythematosus

Intervention

GL701

Location

Genelabs Technologies, Inc.
Redwood City
California
United States
94063

Status

Active, not recruiting

Source

Genelabs Technologies

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:55:02-0400

Clinical Trials [623 Associated Clinical Trials listed on BioPortfolio]

GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids

Open label safety and efficacy follow-up.

Phase II Study of Long-Term Dehydroepiandrosterone for Systemic Lupus Erythematosus

OBJECTIVES: I. Evaluate the long-term safety and tolerance of a synthetic formulation of dehydroepiandrosterone, GL701, in patients with systemic lupus erythematosus who have compl...

Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Active Systemic Lupus Erythematosus

OBJECTIVES: I. Evaluate the safety and efficacy of synthetic dehydroepiandrosterone, GL701, in women with active systemic lupus erythematosus.

To Assess Prevention of Bone Loss in Women With Lupus Receiving Treatment With Glucocorticoids

The purpose of this clinical trial is to study the effects of GL701 on bone mineral density in women with active systemic lupus erythematosus (SLE) who are also receiving treatment with gl...

Duke Lupus Registry

Lupus is a systemic autoimmune disease that can present with many varied symptoms, including joint pain, fevers, kidney disease, and rashes. Lupus can affect anyone, but it is most common...

PubMed Articles [3107 Associated PubMed Articles listed on BioPortfolio]

Recurrent Palisaded Neutrophilic and Granulomatous Dermatitis in the Setting of Systemic Lupus Erythematosus.

We present the case of a 66-year-old woman with a history of systemic lupus erythematosus, who presented with tender nodules on the forearms. The patient reported an 8-year history of pink bumps on th...

Increased risk of depression in patients with cutaneous lupus erythematosus and systemic lupus erythematosus: a Danish nationwide cohort study.

Reported prevalences of depression in patients with systemic lupus erythematosus (SLE) range widely, while the prevalence of depression in cutaneous lupus erythematosus (CLE) remains severely understu...

Hair and Scalp Changes in Cutaneous and Systemic Lupus Erythematosus.

Cutaneous and systemic lupus erythematosus (SLE) commonly involves the hair and scalp. Alopecia can result from direct activity of disease on the scalp or from the state of physical stress in the form...

A case report of lupus erythematosus tumidus converted from discoid lupus erythematosus.

Lupus erythematosus tumidus (LET) is an uncommon type of cutaneous lupus erythematosus (CLE) that is rarely associated with other forms of lupus erythematosus.

Cardiovascular disease in systemic lupus erythematosus: an update.

The mechanisms leading to the development of premature atherosclerosis and vascular injury in systemic lupus erythematosus (SLE) remain to be fully elucidated. This is a comprehensive review of recent...

Medical and Biotech [MESH] Definitions

A form of lupus erythematosus in which the skin may be the only organ involved or in which skin involvement precedes the spread into other body systems. It has been classified into three forms - acute (= LUPUS ERYTHEMATOSUS, SYSTEMIC with skin lesions), subacute, and chronic (= LUPUS ERYTHEMATOSUS, DISCOID).

A chronic form of cutaneous lupus erythematosus (LUPUS ERYTHEMATOSUS, CUTANEOUS) in which the skin lesions mimic those of the systemic form but in which systemic signs are rare. It is characterized by the presence of discoid skin plaques showing varying degrees of edema, erythema, scaliness, follicular plugging, and skin atrophy. Lesions are surrounded by an elevated erythematous border. The condition typically involves the face and scalp, but widespread dissemination may occur.

Antiphospholipid antibodies found in association with systemic lupus erythematosus (LUPUS ERYTHEMATOSUS, SYSTEMIC;), ANTIPHOSPHOLIPID SYNDROME; and in a variety of other diseases as well as in healthy individuals. The antibodies are detected by solid-phase IMMUNOASSAY employing the purified phospholipid antigen CARDIOLIPIN.

Autoantibodies directed against phospholipids. These antibodies are characteristically found in patients with systemic lupus erythematosus (LUPUS ERYTHEMATOSUS, SYSTEMIC;), ANTIPHOSPHOLIPID SYNDROME; related autoimmune diseases, some non-autoimmune diseases, and also in healthy individuals.

An antiphospholipid antibody found in association with systemic lupus erythematosus (LUPUS ERYTHEMATOSUS, SYSTEMIC;), ANTIPHOSPHOLIPID SYNDROME; and in a variety of other diseases as well as in healthy individuals. In vitro, the antibody interferes with the conversion of prothrombin to thrombin and prolongs the partial thromboplastin time. In vivo, it exerts a procoagulant effect resulting in thrombosis mainly in the larger veins and arteries. It further causes obstetrical complications, including fetal death and spontaneous abortion, as well as a variety of hematologic and neurologic complications.

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