Ascending-Dose Extended Cycle Regimen for Breakthrough Bleeding
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Solution Overview
Problem
Conventional oral contraceptives with reduced doses of estrogen and progestin have increased bleeding problems, particularly in the early months of use and persistently in some patients, necessitating a need for contraceptives that reduce bleeding issues and offer additional benefits for women.
Innovation Solution
An ascending-dose extended cycle regimen involving the administration of estrogen and progestin for greater than 30 consecutive days, with phased dosages where the daily dosage of estrogen and progestin increases across phases, providing contraceptive and non-contraceptive benefits such as reduced breakthrough bleeding.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If reduced doses of estrogen and progestin are used in conventional oral contraceptives, then contraceptive safety and side effect profile are improved, but breakthrough bleeding problems increase
Solution Approach 1:
The patent implements dynamic dosing by transitioning from static reduced doses to an ascending dose regimen where estrogen and progestin doses are gradually increased over the first 3-4 weeks of treatment. This dynamic adjustment allows the body to adapt progressively, reducing breakthrough bleeding while maintaining the safety profile of lower long-term doses.
Solution Approach 2:
The patent changes the dosage parameter from a fixed reduced dose to a time-dependent ascending dose schedule. The regimen specifies progressive dose increases during the initial treatment phase, then transitions to lower maintenance doses, thereby optimizing both bleeding control and side effect minimization through parameter variation.
2Reliability
If extended cycle regimens are used (greater than 30 consecutive days), then contraceptive effectiveness and non-contraceptive benefits are improved, but cycle control challenges increase
Solution Approach 1:
The patent applies preliminary action by implementing an ascending dose preparation phase during the first 3-4 weeks before transitioning to the extended cycle regimen. This preparatory period allows the endometrium and hormonal system to adapt progressively, making the subsequent extended cycle (35-90 days) more tolerable and easier to control.
Solution Approach 2:
The regimen uses dynamic dosing strategies with different phases: an ascending dose phase for adaptation, followed by a maintenance phase with lower doses during the extended cycle. This dynamic approach maintains contraceptive effectiveness while improving cycle control and reducing side effects during the extended regimen.
Data Source
AI summary
The present invention provides ascending-dose extended cycle regimens in which a female is administered an estrogen and a progestin for a period of greater than 30 or 31 consecutive days, optionally followed by a hormone-free period or by a period of administration of estrogen. The disclosed regimens can be administered to a female to provide contraceptive and non-contraceptive benefits.