ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT00000420
Date of registration:	03/11/1999
Prospective Registration:	No
Primary sponsor:	New York University School of Medicine
Public title:	Safety of Estrogens in Lupus: Birth Control Pills
Scientific title:	Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Oral Contraceptives
Date of first enrolment:	June 1997
Target sample size:	350
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT00000420
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Phase:	Phase 3

Countries of recruitment
United States

Contacts

Name:	Jill P. Buyon, MD
Address:
Telephone:
Email:
Affiliation:	Hospital for Joint Diseases

Name:	Michelle Petri, MD
Address:
Telephone:
Email:
Affiliation:	Johns Hopkins University Hospital, Dept. of Rheumatology

Key inclusion & exclusion criteria

Inclusion Criteria:

- Female

- Unequivocal diagnosis of SLE

- Inactive disease or be stable on 0.5 mg/kg/day or less of predisone

- Must be between 18 and 39 years old if non-smoker

- Must be between 18 and 35 years old if smoker

Exclusion Criteria:

- Blood pressure >145/95 on three occasions

- Deep vein, arterial thrombosis or pulmonary embolus

- GPL >40; MPL >40; APL >50; dRVVT >37 sec

- APL antibody syndrome ever

- Gynecologic or breast cancer

- Hepatic dysfunction or liver tumors

- Diabetes mellitus (NOT due to steroids) with vascular disease

- Congenital hyperlipidemia

- Complicated migraine

- Severe disease activity (SLEDAI >12)

- Increase in SLEDAI >2 points in 3 months

- Unexplained vaginal bleeding

- Use of estrogen (OCP) for >1 month at any time after SLE diagnosis

- Present pregnancy

- Angina or MI due to APS

- Age >35 yrs. for smokers; >39 yrs. for nonsmokers

Age minimum: 18 Years
Age maximum: 39 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Ortho-Novum 777

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

U01AR042540

U01 AR42540 NIAMS-028B

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Office of Research on Women's Health (ORWH)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.