Long-acting hormonal contraception.

Today, a new category of fertility-regulating agents has been created: long-acting, reversible hormonal contraceptives; they minimize compliance, while maximize effectiveness. They comprise subdermal implants and intrauterine devices. Other long-acting agents exist, such as Depo Provera and Noristerat.

First phase 1 double-blind, placebo-controlled, randomized rectal microbicide trial using UC781 gel with a novel index of ex vivo efficacy.

Objectives: Successful control of the HIV/AIDS pandemic requires reduction of HIV-1 transmission at sexually-exposed mucosae. No prevention studies of the higher-risk rectal compartment exist. We report the first-in-field Phase 1 trial of a rectally-applied, vaginally-formulated microbicide gel with the RT-inhibitor UC781 measuring clinical and mucosal safety, acceptability and plasma drug levels.

Contraceptive devices: intravaginal and intrauterine delivery systems.

Substances with an antifertility activity can be delivered directly into the vagina and the uterus. Indeed, it has been known for decades that the vaginal mucosa is an excellent way through which to deliver a number of compounds to the general circulation. Research and development efforts have concentrated on rings delivering only progestins, or both an estrogen and a progestin.

Contraceptive devices: subcutaneous delivery systems.

Ever since natural sex hormones have been identified, their structure defined and their synthesis achieved, it became clear that their circulating half-life was too short to allow use in therapy. One of the modalities most thoroughly investigated to prolong their duration of action is to embed them in a polymeric matrix and administer them subcutaneously. Research and development activities of devices to be inserted under the skin have focused upon two modalities: the first utilizes the so-called nonbiodegradable devices, in which the matrix is fixed and the drug is made available through diffusion.

A comparison of techniques to assess cervicovaginal irritation and evaluation of the variability between two observers.

Background: Colposcopy is used to evaluate effects of new vaginal products on cervicovaginal epithelium as part of the US Food and Drug Administration-mandated product approval process, yet few aspects of its use have been investigated.

Objectives: To determine the effect of the colposcopic examination itself on the number and type of findings seen, to compare colposcopy with the AviScope hand-held device and the naked eye and to compare the findings reported by two examiners during a single visit.

Study Design: Fourteen healthy women volunteered for five paired examinations in random order: (1) naked eye inspection plus colposcopy done twice by a single examiner; (2) naked eye inspection plus AviScope examination, then naked eye inspection plus colposcopy by a single examiner; (3) Examination 2 repeated with the order of device reversed; (4) naked eye inspection plus colposcopy done by two examiners; (5) Examination 4 repeated with the order of examiner reversed.

Pharmacokinetics of levonorgestrel 0.75 mg tablets.

This study examined plasma levonorgestrel (LNG) concentrations and pharmacokinetics following oral administration of a single LNG 0.75 mg tablet. Sixteen healthy female volunteers 19-44 years old enrolled in the study.