Progestogen-Only Oral Contraception With Optimized LNG Dosing

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Solution Overview

Problem

Progestogen-only pills (POP) have limited acceptability due to high failure rates, irregular bleeding, and hypoestrogenic/androgenic side effects, limiting their use as a viable contraceptive option.

Innovation Solution

A new POP regimen using 0.110 mg to 0.150 mg of levonorgestrel (LNG) or 0.220 mg to 0.300 mg of norgestrel (NG) administered once daily, without additional hormones, to achieve high contraceptive efficacy, acceptable bleeding patterns, and reduced side effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If a low dose of progestogen (e.g., LNG 0.03 mg/day) is used in POP, then thrombosis risk is reduced, but contraceptive efficacy is insufficient leading to high failure rates

Engineering Contradiction:
Improvethrombosis riskVSAvoidcontraceptive efficacy
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent applies parameter changes by adjusting the progestogen dose to an optimized range (LNG 0.110-0.150 mg/day or NG 0.220-0.300 mg/day) that balances thrombosis risk reduction with sufficient contraceptive efficacy. This intermediate dosing level resolves the contradiction between safety and effectiveness that plagues both low-dose and high-dose POP formulations.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If a high dose of progestogen (e.g., LNG 0.60-0.90 mg/day) is used in POP, then contraceptive efficacy is improved, but hypoestrogenic side effects and androgenic side effects occur

Engineering Contradiction:
Improvecontraceptive efficacyVSAvoidhypoestrogenic and androgenic side effects
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent resolves this contradiction by changing the dosing parameter to an optimized intermediate range (LNG 0.110-0.150 mg/day or NG 0.220-0.300 mg/day). This parameter optimization ensures sufficient contraceptive efficacy while avoiding the hypoestrogenic and androgenic side effects associated with higher doses, as confirmed by maintained estradiol levels and reduced adverse effects in clinical studies.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent applies partial action by using a moderate dose of progestogen that is sufficient to achieve contraceptive efficacy through ovulation inhibition and cervical mucus changes, but not excessive enough to cause significant hormonal side effects. This partial dosing strategy achieves the minimum effective dose without over-suppression of ovarian function.

Inventive Principle:
Principle #16Partial or excessive action

3Reliability

If desogestrel 0.075 mg/day is used in POP, then contraceptive efficacy is improved above ovulation-inhibiting level, but irregular bleeding occurs frequently

Engineering Contradiction:
Improvecontraceptive efficacyVSAvoidirregular bleeding
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent resolves this contradiction by changing both the dose parameter and the progestogen type parameter. Using LNG or NG at optimized doses (LNG 0.110-0.150 mg/day or NG 0.220-0.300 mg/day) produces more stable endometrial effects compared to desogestrel, reducing irregular bleeding while maintaining contraceptive efficacy above the ovulation-inhibiting threshold.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS12485128B2Progestogen-only oral contraception
Publication Date: 2025.12.02 NAVAD LIFE SCIENCES PTE
  • US12485128B2 patent drawing
  • US12485128B2 patent drawing
  • US12485128B2 patent drawing

AI summary

A method for providing progestogen only contraception.