Multiphasic Estrogen Contraceptive Regimen

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Solution Overview

Problem

Existing estrogenic/progestogenic contraceptive regimens face challenges in reducing estrogen levels without compromising contraceptive efficacy or increasing undesired side effects, as it was believed that a minimum of 10 mcg of ethinyl estradiol was necessary for effective contraception.

Innovation Solution

A multiphasic method and kit that administers a progestogen in sequential steps, with significantly reduced or eliminated estrogen in the first phase, followed by increased estrogen in subsequent phases, maintaining contraceptive efficacy and minimizing side effects by allowing a short interim period between phases.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If estrogen is reduced in contraceptive compositions, then undesired side effects are reduced, but contraceptive efficacy is compromised

Engineering Contradiction:
Improveundesired side effectsVSAvoidcontraceptive efficacy
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The contraceptive regimen is divided into multiple phases with different estrogen dosages. Phase 1 uses low or no estrogen (0-10 mcg), Phase 2 uses medium estrogen (10-30 mcg), and Phase 3 uses high estrogen (30-50 mcg). This segmentation allows the system to achieve low side effects during Phase 1 while maintaining efficacy through sufficient estrogen in Phases 2 and 3.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The contraceptive method employs periodic administration of varying estrogen doses throughout the cycle. Instead of continuous high-dose estrogen, the regimen alternates between low-estrogen periods (Phase 1) and higher-estrogen periods (Phases 2-3), achieving overall efficacy while reducing cumulative side effects.

Inventive Principle:
Principle #19Periodic action

2Object-affected harmful factors

If estrogen is eliminated from the first phase, then side effects such as breakthrough bleeding are minimized, but cycle control may be compromised

Engineering Contradiction:
Improvebreakthrough bleedingVSAvoidcycle control
Core Design Contradiction:
Object-affected harmful factorsVSStability of the object's composition

Solution Approach 1:

Phase 1 serves as a preliminary low-estrogen phase that prepares the endometrium for subsequent higher-estrogen phases. By administering progestogen alone or with minimal estrogen first, the system reduces initial breakthrough bleeding while the later phases establish stable cycle control.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The estrogen dosage parameter is dynamically changed throughout the cycle rather than remaining constant. Phase 1 uses 0-10 mcg estrogen, Phase 2 uses 10-30 mcg, and Phase 3 uses 30-50 mcg. This parameter progression allows minimal estrogen exposure initially (reducing side effects) while achieving adequate cycle control through higher doses later.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS9132137B2Graduated estrogen contraceptive
Publication Date: 2015.09.15 ALLERGAN THERAPEUTICS LLC

AI summary

A multiphasic estrogenic/progestogenic contraceptive regimen that provides for the reduction or elimination of estrogen in the initial phase is disclosed. Also described is a contraceptive kit that may be used to practice the method of the invention.