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Triphasic oral contraceptive

A stage, pillbox technology for use in the field of steroid-based three-stage oral contraceptive regimens to address breakthrough bleeding and/or high blood spotting

Inactive Publication Date: 2002-02-06
ORTHO MCNEIL PHARM INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the 20 μg EE regimen, there was a higher rate of significant breakthrough bleeding and / or blood spotting
In the 20 μg EE regimen, there was a higher rate of significant breakthrough bleeding and / or blood spotting
In the 20 μg EE regimen, there was a higher rate of significant breakthrough bleeding and / or blood spotting

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Objectives and methods

[0063] A randomized, multicentre study was conducted to evaluate a triple-blind regimen of norgestimate and ethinyl estradiol (NGE / EE) oral contraceptives as well as an open-labeled control regimen. One of these blinding protocols is the three-stage protocol of the present invention. In this three-stage regimen, a tablet containing 0.180 mg norgestimate + 25 μg EE was used once a day in the first phase for 7 days; in the second phase, a tablet containing 0.215 mg norgestimate + 25 μg EE was used once a day, A total of 7 days; while in the third period, tablets containing 0.250 mg norgestimate + 25 μg EE were used; followed by 7 days with placebo. Across the study, approximately 6300 subjects were enrolled. A 3:2 ratio of subjects was assigned to each triple-blind protocol group to the open-labeled control protocol group. The first 500 subjects in each triple-blind protocol arm are expected to complete 13 cycles. All othe...

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PUM

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Abstract

A method of contraception in which an estrogen and a progestogen are administered daily in a three phase sequence for 21 days is disclosed. In the first phase a combination of an estrogen and a progestogen in a low but contraceptively effective daily dosage corresponding in estrogenic activity to 23-28 mug of 17alpha-ethinylestradiol and in progestogenic activity to 0.065-0.75 mg of norethindrone is administered for 5-8 days; followed by the administering of the same dosage of estrogen and a progestogen corresponding in progestogenic activity to 0.25-1.0 mg of norethindrone for 7-11 days; followed by the administering of the same dosage of estrogen and a progestogen corresponding in progestogenic activity to 0.35-2.0 mg of norethindrone for 3-7 days; followed by 4-8 days without administering either an estrogen or a progestogen.

Description

[0001] The present invention relates to a steroidal three-stage oral contraceptive regimen. More specifically, the present invention relates to a three-phase contraceptive regimen comprising a progestogen and low doses of ethinyl estradiol (EE). Background of the invention [0002] a) Low-dose estrogen regimen [0003] In previous years, it has been recognized that there are certain advantages of steroidal-containing oral contraceptives, OC, which contain lower doses of progestogens and especially lower doses of estrogens. These advantages of lower estrogen doses include a lower incidence of bothersome side effects, such as nausea, vomiting, and upset stomach, and a lower incidence of serious side effects, such as thromboembolism, stroke, and myocardial infarction. Thus, while the advantages of steroid-containing contraceptives are generally recognized in the medical community, the lowest effective amount of steroid needs to be administered to the patient on a patient-by-pati...

Claims

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Application Information

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IPC IPC(8): A61K31/565A61K31/567A61K31/569A61K31/57A61P15/18
CPCA61K31/565A61K31/57A61P15/18A61K2300/00
Inventor G·尚戈尔德A·鲁宾D·乌普马利斯
Owner ORTHO MCNEIL PHARM INC
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