Vaginal dispenser for dispensing beneficial hormone

• US 4,629,449 A
• Filed: 03/21/1985
• Issued: 12/16/1986
• Est. Priority Date: 07/29/1982
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Wong, Patrick S.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US06/714,421
• Time in Patent Office: 635 Days
• Field of Search: 128/127, 128/130, 424/DIG. 7, 424/15, 424/14, 424/16, 424/19, 424/31, 604/890, 604/892, 604/99, 604/893, 604/54-56, 604/285, 604/288
• US Class Current: 604/515
• CPC Class Codes: A61K 9/0036 Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

The invention is for a method of treating a decrease in estrogen secretion in a woman after the cessation of cyclic ovulation using a vaginal dispenser comprising a wall surrounding an internal lumen and having a pair of ends with one end placed inside the other end to form a closed dispenser. A vaginally administrable beneficial agent is housed in the lumen for release by the dispenser over time.

Claims

1. A method of treating a decrease in estrogen secretion in a woman exhibiting symptoms of a cessation of cyclical ovulation, which method comprises:

(a) placing in the vagina of a woman exhibiting symptoms of a cessation of cyclical ovulation a dispenser adapted and shaped for easy placing and comfortable retention in the vagina, the dispenser comprising;

(1) body means for housing and estrogen, which body means comprises a vaginally acceptable composition that is essentially-free of deleterious action on the vaginal tissues; and

,

(2) means in the dispenser for dispensing the estrogen from the dispenser over a prolonged period of time;

(b) dispensing the estrogen from the dispenser into the vagina of said woman in a therapeutically effective amount for replacing estrogen and treating the decrease in said woman.

2. The method of treating a decrease in estrogen secretion in the woman in need of estrogen replacement according to claim 1, wherein the estrogen is a member selected from the group consisting of naturally occurring and synthetic estrogens.

3. The method of treating a decrease in estrogen secretion in the woman in need of estrogen replacement according to claim 1, wherein the estrogen is a member selected from the group consisting of estradiol, estradiol benzoate, estradiol cypionate, estradiol dipropionate, estradiol enanthate, conjugated estrogen, estriol, estrone, estrone sulfate, ethinyl estradiol, estrofurate, quinestrol and mestranol.

4. The method of treating a decrease in estrogen secretion in the woman in need of estrogen replacement according to claim 1, wherein the estrogen in the body means is present as a composition comprising an estrogenic and a progestational steroids.

5. A method for relieving the symptoms associated with menopausal, perimenopausal and post-menopausal periods in a woman having said periods and in need of estrogen therapy, which method comprises:

(a) placing in the vagina of a menopausal, perimenopausal and postmenopausal woman a dispenser adapted and sized for easy placing and comfortable retention in the vagina, the dispenser comprising;

(1) body means for housing an estrogen, which body means comprises a vaginally acceptable composition that is essentially-free of deleterious action on the vaginal environment; and

,

(2) means in the dispenser for dispensing the estrogen from the dispenser over a prolonged period of time; and

(b) dispensing into the vagina from the dispenser the estrogen in a therapeutically effective amount for relieving the symptoms associated with menopausal perimenopausal and postmenopausal period in said woman.

6. A method for relieving the symptoms associated with the menopausal, perimenopausal and postmenopausal periods in a woman having said periods and in need of estrogen therapy, which method comprises:

(a) positioning in the vagina of said woman a vaginal dispenser, said vaginal dispenser comprising;

(1) body means for housing an estrogenic steroid, said body means comprising a non-toxic, vaginally acceptable, flexible polymeric composition shaped and sized for easy positioning and comfortable retention in the vagina over a prolonged period of time;

(2) an estrogenic steroid useful for estrogen therapy in the dispenser present in an amount sufficient for relieving the symptoms;

(3) releasing means in the dispenser for dispensing the estrogen from the dispenser over a prolonged period of time; and

,

(b) relieving the symptoms associated with the menopausal, perimenopausal and postmenopausal periods by delivering the estrogenic steroid in a therapeutically effective amount from the vaginal dispenser to the vagina to produce the intended therapy in said woman over a prolonged period of time.