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New long-acting injectable microcapsule contraceptive system.

L R Beck, D R Cowsar, D H Lewis

American Journal of Obstetrics and Gynecology

|October 1, 1979

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A novel injectable contraceptive using biodegradable microcapsules provides 6 months of continuous norethisterone (NET) release. This new long-acting formulation effectively inhibits ovulation in baboons, offering a promising contraceptive option.

Area of Science:

Reproductive Medicine
Biomaterials Science
Pharmacology

Background:

Development of long-acting injectable contraceptives is crucial for family planning.
Existing methods may have limitations in duration or side effects.
Controlled-release drug delivery systems offer potential for improved contraceptive efficacy and convenience.

Purpose of the Study:

To describe a new long-acting, injectable contraceptive system.
To evaluate the controlled release of norethisterone (NET) over 6 months.
To assess the contraceptive efficacy of the NET microcapsule system in a primate model.

Main Methods:

A prototype injectable contraceptive system using biodegradable d, l-polylactic acid microcapsules homogeneously dispersed with micronized norethisterone (NET) was developed.

Keywords:

Animals, Laboratory Biology Clinical Research Contraception Contraceptive Agents, Female--administraction and dosage Contraceptive Agents, Female--analysis Contraceptive Agents, Progestin--administraction and dosage Contraceptive Agents, Progestin--analysis Contraceptive Agents--administraction and dosage Contraceptive Agents--analysis Contraceptive Methods Endocrine System Estrogens--analysis Family Planning Hormones Injectables Norethindrone--administraction and dosage Norethindrone--analysis Physiology Progestational Hormones Progesterone--analysis Research Methodology

Related Experiment Videos

Three different doses of NET microcapsules were administered intramuscularly to female baboons.

Serum levels of NET, estrogen, and progesterone were analyzed via radioimmunoassay to assess drug release and hormonal profiles.

Main Results:

All tested doses of the NET microcapsule preparation demonstrated continuous controlled release of norethisterone for a 6-month period.
Radioimmunoassay confirmed parallel serum NET profiles across the different dosage groups.
Ovulation was successfully inhibited in all treated baboons for the entire 6-month duration.

Conclusions:

The developed biodegradable microcapsule system provides effective, continuous, and controlled release of norethisterone for 6 months.
This long-acting injectable contraceptive formulation demonstrates significant potential for preventing ovulation.
The technology represents a promising advancement in long-acting reversible contraception.