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Back to Gynecology Articles

Monday, 24th October, 2005

 

Lybrel is an investigational combination low-dose oral contraceptive designed to be taken daily, 365 days a year.

 
 

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  Highlights From The Conjoint Meeting Of The ASRM/CFAS 2005  
   

Madison, N.J., Wyeth Pharmaceuticals, a division of Wyeth, announced that four scientific abstracts regarding Lybrel? (0.09 mg levonorgestrel/0.02 mg ethinyl estradiol tablets) were presented for the first time today at the 61st Annual Meeting of the American Society for Reproductive Medicine (ASRM) in Montr?l, Canada.

The studies investigated the effects of 0.09 mg levonorgestrel/0.02 mg ethinyl estradiol on ovarian activity, safety and efficacy, endometrial histology, and cycle-related symptoms. The New Drug Application (NDA) for the study drug, Lybrel, a combination low-dose oral contraceptive designed to be taken daily, 365 days a year, without a placebo phase or pill-free interval, was accepted for filing on July 27, 2005 and is currently under review by the U.S. Food and Drug Administration (FDA).

The research presented at the ASRM Annual Meeting includes investigational data on multiple effects of 0.09 mg levonorgestrel/0.02 mg ethinyl estradiol. The abstracts accepted for presentation are:

Investigation of Ovarian Activity

A six-month Phase 2 study entitled ?Effect on Ovarian Activity of a Continuous-Use Regimen of Oral Levonorgestrel/Ethinyl Estradiol? reported that participants (n=37) taking 0.09 mg levonorgestrel/0.02 mg ethinyl estradiol experienced inhibition of ovulation. The study also reported that participants who stopped the study drug treatment demonstrated a return to ovulation. This was the first ever published investigational study of a combination oral contraceptive designed to be taken every day of the year without a placebo phase to specifically evaluate ovarian suppression and return to ovulation.

Investigation of Safety and Efficacy

An abstract entitled ?Efficacy and Safety of a Continuous-Use Regimen of Levonorgestrel/Ethinyl Estradiol: North American Phase 3 Study Results? examined the contraceptive effects of 0.09 mg levonorgestrel/0.02 mg ethinyl estradiol and the adverse events experienced by the study participants (n=2,134) during the 12-month trial. Contraceptive efficacy was determined by the Pearl Index, a calculation of the pregnancy rate among study participants.

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?In this study, the investigational drug was greater than 98 percent effective in preventing pregnancy,? says Dr. David Archer, Director, CONRAD Clinical Research Center, Professor of Obstetrics and Gynecology, Eastern Virginia Medical School and investigator in this trial. ?This rate is consistent with currently available oral contraceptive products.?

In addition, there was a steady increase from baseline in the percentage of
participants who reported amenorrhea and no bleeding: 44.8 percent and 70.8 percent, respectively, by pill pack seven.

Among the trial participants, the safety profile of 0.09 mg levonorgestrel/0.02 mg ethinyl estradiol was reported as consistent with that of currently approved cyclic oral contraceptives. Safety was assessed by physical exams, clinical laboratory tests, and adverse event records. Six serious adverse events which were possibly related to the drug were reported: cholecystitis (2), deep vein thrombosis/pulmonary embolism (1), ectopic pregnancy (1), prolonged vaginal bleeding (1) and enlarged uterine fibroids (1).

Investigation of Endometrial Histology

An abstract entitled ?Endometrial Histology in Subjects on a Continuous-Use Regimen of Levonorgestrel/Ethinyl Estradiol: Results of a Phase 3 Study? detailed the endometrial safety profile for 0.09 mg levonorgestrel/0.02 mg ethinyl estradiol. During the trial, endometrial changes among the participants (n=93) were consistent with a decrease in endometrial growth and decidualization compared to baseline and no instances of malignancies were reported during the 12-month trial period.

Investigation of Effect on Cycle-Related Symptoms

An abstract entitled ?A Continuous-Use Regimen of Levonorgestrel/Ethinyl Estradiol Significantly Alleviates Cycle-Related Symptoms: Results of a Phase 3 Study? explored the effects of 0.09 mg levonorgestrel/0.02 mg ethinyl estradiol on alleviating cycle-related symptoms. Symptoms were recorded using the Penn Daily Symptom Rating (DSR) diary, a tool designed to assess premenstrual syndrome (PMS). During the three-month, open-label substudy, participants with a history of cycle-related symptoms (n=36) or PMS (n=78) reported a decrease in symptoms compared to baseline by the first pill pack, and continued to report a decrease in symptoms during the two subsequent pill packs.

About 0.09 mg Levonorgestrel/0.02 mg Ethinyl Estradiol

On July 27, Wyeth announced that the FDA accepted for filing the Company?s NDA for Lybrel (0.09 mg levonorgestrel/0.02 mg ethinyl estradiol tablets), an investigational combination oral contraceptive with a low dosing regimen. Wyeth is seeking market approval for 0.09 mg levonorgestrel/0.02 mg ethinyl estradiol tablets for the prevention of pregnancy in women who elect to use oral contraception and who have no known contraindications for this method of contraception. If approved, this investigational product will contain a low daily dose of ethinyl estradiol and levonorgestrel, a well-studied combination. It is expected to be the only combination oral contraceptive approved with this regimen designed to be taken daily, 365 days a year, without a placebo phase or pill-free interval. If approved, this product will also allow a woman to stop the hormonal fluctuations associated with the entire menstrual cycle.

Filing an NDA with the FDA is an important step in the approval process in the United States. Acceptance for filing does not indicate that approval has been or will be issued, nor does it represent an evaluation of the adequacy of the data submitted.

?The science to support 0.09 mg levonorgestrel/0.02 mg ethinyl estradiol is an important evolution for oral contraceptives. As a leader in women?s health care, Wyeth is developing this oral contraceptive so that women may have additional contraceptive options,? says Dr. Ginger Constantine, Vice President, Women?s Health Care and Bone Repair, Wyeth Pharmaceuticals.

 

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