The Population Council, Inc.

The Population Council, Center for Biomedical Research

C Wayne Bardin

Harold A Nash

Saleh Ismail Saleh

Troy Harmon

Michael G Rosenfeld

Peter N Schlegel

C Yan Cheng

Richard V Pearse

Bogi Andersen

Carl Monder

Disclosed is a vaginal ring intended for the release of at least one drug over a prolonged time period. The vaginal ring contains a ring body made of a first polymeric material having at least one hollow internal channel defining an opening to the exterior of said body and which channel is adapted to receive a drug-containing core through said opening, and an intravaginally administerable drug-containing core disposed in the channel. The core is positioned in the vaginal ring body suitably prior to use in order to substantially avoid initial bursts of drug into the tissues of the subject and resultant side effects such as nausea and vomiting. The core contains a pharmaceutically effective amount of at least one intravaginally administerable drug dispersed in a second polymeric material. The first and second polymeric materials may be the same or different. Representative drugs include contraceptive agents and other steroidal substances for use in hormone replacement therapy. Also disclosed are methods for preparing the vaginal rings, kits for assembling the vaginal rings, and methods of using the vaginal rings to achieve intravaginal delivery of drugs to a female.

Intravaginal rings with insertable drug-containing core

Disclosed is a vaginal ring intended for the release of at least one drug over a prolonged time period. The vaginal ring contains a ring body made of a first polymeric material having at least one hollow internal channel defining an opening to the exterior of the ring body and which channel is adapted to receive a, drug-containing core through the opening, and an intravaginally administerable drug-containing core disposed in the channel. The core is positioned in the vaginal ring body suitably prior to use in order to substantially avoid initial bursts of drug into the tissues of the subject and resultant side effects such as nausea and vomiting. The core contains a pharmaceutically effective amount of at least one intravaginally administerable drug dispersed in a second polymeric material. The first and second polymeric materials may be the same or different. Representative drugs include contraceptive agents and other steroidal substances for use in hormone replacement therapy. Also disclosed are methods for preparing the vaginal rings, kits for assembling the vaginal rings, and methods of using the vaginal rings to achieve intravaginal delivery of drugs to a female.

Disclosed is a POU transcription factor, Sprm-1 and analogs thereof, DNA molecules encoding the Sprm-1 proteins, and chimeric constructs, vectors and host cells containing the DNA molecules. Also disclosed are methods to identify putative male contraceptive agents. One involves the steps of isolating a DNA regulatory region responsive to Sprm-1, stably transforming a heterologous cell line with a first chimeric DNA construct containing a constitutive promoter capable of functioning in the cell line operably linked to a Sprm-1 DNA and a second chimeric DNA construct containing the DNA regulatory region operably linked to a reporter gene. The thus-transformed cell line is cultural in media containing the compound so that the thus-cultured cell line can be assayed to determine the Sprm-1 inhibitory activity of the compound. The above method can be modified to evaluate the Sprm-1 inhibitory activity of DNA molecules of interest, by transiently transfecting the thus-transformed cell line with a third DNA construct containing a constitutive promoter capable of functioning in the cell line operably linked to the DNA molecule, and then culturing the thus-transfected cell line so that it can be assayed to determine the inhibitory activity of the DNA molecule. Antibodies specific to Sprm-1, and their use in diagnosing male germ cell Sprm-1-mediated diseases or conditions are further disclosed.

Isolated DNA molecule encoding SPRM-1 protein

A particular group of androgens is not metabolized to their 5.alpha.-reduced form in the prostate and other tissues. Thus, administration of these compounds--testosterone derivatives with a non-hydrogen substituent in the 6.alpha. or 7.alpha. position--allows one to provide androgen supplementation therapy without stimulating abnormal prostate growth. A preferred compound for use in the invention is 7.alpha.-methyl-19-nortestosterone.

Method for androgen supplementation

The present invention relates to a compound which when administered to Leydig cells in the testes stimulates the production of androgen such as testosterone. This compound, when mixed with other known compounds, can produce testosterone levels in excess of those obtained by the administration of a maximal stimulatory dose of Lutenizing Hormone (LH).

Growing community of inventors

New York, NY, United States of America

C Wayne Bardin