SETLAKIN

Post-LOE

levonorgestrel and ethinyl estradiol

Xeltis

ANDAORALTABLET

Approved

Sep 2014

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

SETLAKIN (levonorgestrel and ethinyl estradiol) by Xeltis is clinical pharmacology mode of action combination oral contraceptives act by suppression of gonadotropins. Approved for pregnancy in women. First approved in 2014.

Drug data last refreshed 21h ago

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Mechanism of Action

CLINICAL PHARMACOLOGY Mode of Action Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus)…

Indications (1)

pregnancy in women

Clinical Trials (7)

NCT02159131Phase 1Completed

Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Levonorgestrel and Ethinyl Estradiol When Co-administered With GSK1265744 in Healthy Adult Female Subjects

Started Aug 2014

20 enrolled

Infections, Human Immunodeficiency Virus and Hepatitis

NCT00918476Phase 1Completed

Investigation Of The Effect Of Steady State Filibuvir On The Pharmacokinetics Of Oral Contraceptives (Levonorgestrel And Ethinyl Estradiol)

Started Jun 2010

14 enrolled

Hepatitis C

NCT01243580Phase 1Completed

AG200-15 Transdermal Contraceptive Delivery System (TCDS) of Levonorgestrel and Ethinyl Estradiol

Started Aug 2009

36 enrolled

Healthy

NCT00195559Phase 3Completed

Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder

Started Sep 2005

526 enrolled

Premenstrual SyndromeMenstruation Disturbances

NCT00245921Phase 3Completed

Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

Started Feb 2003

2,000 enrolled

Contraception

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.