Development of a low-dose monthly injectable contraceptive system: II. Pharmacokinetic and pharmacodynamic studies.

Abstract:

:A drug delivery system which provides a sustained release of norethindrone (NET) and mestranol (ME) for one month after a single intramuscular injection was assessed as a long-acting injectable contraceptive. The system is based upon well defined particle size crystals of the synthetic steroids maintained in suspension with saline solution. Eight healthy ovulating women volunteered for the study; they received a combination of 10 mg of NET plus 1 mg of ME in 1 ml of vehicle by intramuscular injection on day five of their menstrual cycle. Blood samples were drawn at 0, 1, 5, 10, 13, 17 and 21 days after drug administration. The immunoreactive serum levels of estradiol, progesterone, NET and ethinylestradiol were measured by specific radioimmunoassay procedures to assess ovarian function and the kinetic parameters of the synthetic steroids. This newly developed contraceptive system proved to be both effective, and long-lasting as well as devoid of side effects.

journal_name

Contraception

journal_title

Contraception

authors

Díaz-Sánchez V,Garza-Flores J,Jimenéz-Thomas S,Rudel HW

doi

10.1016/0010-7824(87)90051-5

subject

Has Abstract

pub_date

1987-01-01 00:00:00

pages

57-68

issue

1

eissn

0010-7824

issn

1879-0518

pii

0010-7824(87)90051-5

journal_volume

35

pub_type

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