These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


Pubmed for Handhelds

PUBMED FOR HANDHELDS

Search MEDLINE/PubMed

  • Title: FHI's role in search for nonsurgical sterilization.
    Journal: Netw Res Triangle Park N C; 1994 May; 14(4):26-9. PubMed ID: 12287743.
    Abstract:
    Nonsurgical female sterilization, through use of quinacrine hydrochloride pellets inserted into the uterus, has the potential to make low cost permanent contraception accessible to the millions of women in developing countries who desire no more children but do not live close to surgical facilities or cannot spend time away from their families. Family Health International (FHI) has been studying this agent in clinical trials in Chile since 1976. The efficacy rate for 2 100-minute pellets is 95-98% at 12 months. The predominant side effects, temporary and minor, are amenorrhea of 1-3 months' duration, lower back pain, heavier menstrual bleeding, and headache. In 1990, however, FHI withdrew its Investigational New Drug application to explore the agent's toxicity, teratogenicity, and carcinogenicity. In 1989, 8 cases of cancer in 6 different anatomical sites were identified among the 572 Chilean women who had received quinacrine in clinical trials in the preceding decade. A retrospective study of 1492 Chilean women who were sterilized with quinacrine in 1977-89 revealed 17 cancer cases. Small sample sizes and the lack of cancer incidence data in Chile make it impossible to draw conclusions on the drug's carcinogenicity, but FHI will monitor this group for another 5 years. Early preclinical studies in pregnant rats and monkeys have indicated high rates of fetal death but no evidence of chromosomal damage; however, these studies must be repeated to meet new requirements, including the evaluation of bacterial gene mutation, mammalian cell gene maturation, and in vitro cytogenetics. Another research site has been Vietnam, where 31,781 quinacrine pellet sterilizations were performed in 1989-92 at the request of the government. FHI researchers are collecting data on health related outcomes as well as acceptor satisfaction, provider counseling, and service delivery among 1800 of these women and will complete its study in 1994. If the toxicology study yields favorable results, clinical trials will be repeated in the US.
    [Abstract] [Full Text] [Related] [New Search]