MYZILRA (ethinyl estradiol) · PH HEALTH
MYZILRA is a combination oral contraceptive (COC) containing the progestin levonorgestrel and the estrogen ethinyl estradiol. It is indicated for use by females of reproductive potential to prevent pregnancy.
How MYZILRA Works
This medication prevents pregnancy primarily by suppressing ovulation. It may also cause thickening of the cervical mucus, which inhibits sperm migration, and alterations in the endometrium to reduce the likelihood of implantation.
Details
- Status
- Discontinued
- First Approved
- 2011-11-23
- Routes
- ORAL-28
- Dosage Forms
- TABLET
MYZILRA Approval History
What MYZILRA Treats
1 FDA approvalsOriginally approved for its first indication in 2011 .
- Other (1)
Other
(1 approval)- • Approved indication (Nov 2011)
MYZILRA Boxed Warning
Cigarette smoking increases the risk of serious cardiovascular side effects from oral-contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke....
Cigarette smoking increases the risk of serious cardiovascular side effects from oral-contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07340190 | CDAK539A12102 2025-521000-22-00, 2025 | Ph 1 | recruiting | A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies |
| NCT07339722 | 27789 J6V-MC-OIAB | Ph 1 | recruiting | A Study of LY4515100 in Healthy Participants |
| NCT06039826 | 18533 J1I-MC-GZBV | Ph 1 | completed | A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MYZILRA FDA Label Details
Indications & Usage
Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use Myzilra ® Tablets as a method of contraception. Oral contraceptives are highly effective. TABLE I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE I: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE ...
Cigarette smoking increases the risk of serious cardiovascular side effects from oral-contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.