Abstract: The present invention relates to an improvement in a method of contraception, in treatment of benign gynecological disorders, and in hormone replacement. The improved method includes administering intranasally an estrogenic compound and an androgenic compound, and in some embodiments an optional progestin compound, in a once-daily bolus formulation comprised of the two or three steroids complexed with a cyclodextrin. An intranasal delivery system for administration of the formulation is also described.
Type:
Grant
Filed:
November 15, 2002
Date of Patent:
April 18, 2006
Assignee:
Balance Pharmaceuticals, Inc.
Inventors:
Malcolm C. Pike, Darcy V. Spicer, AnnaMarie Daniels, John R. Daniels
Abstract: An improvement in a method of treating benign gynecological disorders is described. In the method, treatment of a benign gynecological disorder with a composition comprised of a gonadotropin releasing hormone (GnRH) compound and an estrogenic compound, and optionally, an androgenic compound, is extended to premenopausal women who are not receiving an exogenously supplied progestin on a regular or periodic basis. Treatment in accord with the invention does not increase significantly the risk of endometrial hyperplasia. The method is also suitable for contraception.
Type:
Grant
Filed:
November 15, 2002
Date of Patent:
November 1, 2005
Assignee:
Balance Pharmaceuticals, Inc.
Inventors:
Anne-Marie Daniels, John R. Daniels, Malcolm C. Pike, Darcy V. Spicer
Abstract: A nasal spray formulation for use in female contraception or in the treatment of benign gynecological disorders is described. The nasal preparation is comprised of a GnRH compound and an estrogenic compound in the form of a water-soluble complex with a water-soluble cyclodextrin. The preparation effectively suppresses ovarian estrogen and progesterone production, and prevents signs and symptoms of estrogen deficiency, without a significant increase in the risk of endometrial hyperplasia.
Type:
Grant
Filed:
November 15, 2002
Date of Patent:
October 25, 2005
Assignee:
Balance Pharmaceuticals, Inc.
Inventors:
John R. Daniels, Malcolm C. Pike, Darcy V. Spicer, AnnaMarie Daniels
Abstract: Compositions and methods for use in preventing conception or treating benign gynecological disorders, wherein an effective amount of an antiprogestational agent [e.g., progesterone (progestin, progestogen, gestagen) antagonist or progesterone synthesis inhibitor] administered over a first period of time is combined with an effective amount of a progestogen for a second period of time. The antiprogestational agent is selected from single agents or mixtures thereof. The progestogen is selected from single agents or mixtures of natural or synthetic progestogens. The formulations are effective as contraceptive agents and for treatment of benign gynecological disorders including uterine fibroids, premenstrual syndrome, dysfunctional uterine bleeding, polycystic ovarian syndrome and endometriosis.
Type:
Application
Filed:
May 1, 2001
Publication date:
August 23, 2001
Applicant:
Balance Pharmaceuticals, Inc.
Inventors:
Darcy V. Spicer, Malcolm Cecil Pike, John R. Daniels
Abstract: Compositions and methods for use in preventing conception or treating benign gynecological disorders, wherein an effective amount of an antiprogestational agent [e.g., progesterone (progestin, progestogen, gestagen) antagonist or progesterone synthesis inhibitor] administered over a first period of time is combined with an effective amount of a progestogen for a second period of time. The antiprogestational agent is selected from single agents or mixtures thereof. The progestogen is selected from single agents or mixtures of natural or synthetic progestogens. The formulations are effective as contraceptive agents and for treatment of benign gynecological disorders including uterine fibroids, premenstrual syndrome, dysfunctional uterine bleeding, polycystic ovarian syndrome and endometriosis.
Type:
Grant
Filed:
June 18, 1997
Date of Patent:
May 1, 2001
Assignee:
Balance Pharmaceuticals, Inc.
Inventors:
Darcy V. Spicer, Malcolm Cecil Pike, John R. Daniels