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PubMed1999

Evaluation of conjugated estrogen plus medroxyprogesterone acetate versus tibolone in early postmenopausal Chinese women.

BACKGROUND: The safety and efficacy of tibolone (Livial) were compared with the traditional cyclic, sequential conjugated estrogens/medroxyprogesterone acetate (Premarin/Provera; PP) regimen for the treatment of climacteric symptoms, prevention of postmenopausal bone loss, endometrial stimulation and influence on lipid profile. METHODS: Forty women, one to three years postmenopause, were randomly enrolled in one of two treatment groups, receiving either tibolone (2.5 mg) every day for six months or Premarin (0.625 mg) every day plus Provera (5 mg) from day 1 to day 12 every month for six months. The scores of climacteric complaints, using the Greene Climacteric Scales, and bleeding pattern were recorded at baseline and follow-up visits at months 1, 3 and 6. Bone resorption (deoxypyridinium) and formation (osteocalcin) markers were measured at baseline, three and six months. Lipid profiles, bone density of the lumbar spine and neck of the femur measured by dual energy X-ray absorptiometry were checked at baseline and six months. RESULTS: Tibolone was as effective as PP in alleviating climacteric complaints. Both regimens were effective in slowing bone metabolism and preventing bone loss. After six months of treatment, bone density of the lumbar spine increased 2.174% in the tibolone group. The endometrium of patients remained atrophic (< 4 mm); only one woman reported vaginal spotting after three months of tibolone therapy. Significant decreases in triglyceride (31.48%) and high-density lipoprotein (29.25%) were also observed. In the PP group, bone density of the lumbar spine increased 1.405%; cyclic withdrawal bleeding occurred in every patient. A significant increase in triglyceride (38.76%) and a significant decrease in low-density lipoprotein (15.10%) were observed. CONCLUSIONS: Tibolone proved to be effective and safe in the treatment of women with climacteric symptoms and postmenopausal bone loss. As a form of hormone replacement therapy without the need for withdrawal bleeding, tibolone has great appeal to postmenopausal women, and compliance is higher than reported with other forms of hormone replacement therapy.

Bone Density↗
PubMed1999

[A case of breast cancer with liver metastases responding remarkably to combination therapy of mitoxantrone (MIT), doxifluridine (5'-DFUR) and medroxyprogesterone acetate (MPA)].

A 60-year-old woman with her right breast cancer showing simultaneous and multiple liver metastases was initially treated with CEFT [cyclophosphamide (CPA), epirubicin (epi-ADM), 5-fluorouracil (5-FU), tamoxifen (TAM)]. After one treatment course the primary lesion did not decrease while tumor markers and liver lesion size increased. Therefore, the foul-smelling primary lesion was resected followed by treatment with mitoxantrone (MIT), 10 mg intravenously every 4 weeks as well as daily/oral administrations of doxifluridine (5'-DFUR) and medroxyprogester-one acetate (MPA). Following MIT administration, the tumor markers decreased markedly, so treatment was continued. After the third course, therapy was continued on an outpatient basis. During treatment WBC reduction to about 3,000/microliter was the only adverse reaction. After 10 courses, the tumor markers were normal, and after 15 courses there were no liver metastases on abdominal CT. Generally, patients with resistance to standard anthracycline chemotherapy are difficult to treat. Those with liver metastasis especially have a poor response which results in a poor prognosis. However, therapy with MIT, 5'-DFUR and MPA may be useful in previously treated, advanced and recurrent breast cancer. Furthermore, this therapy can be done on an outpatient basis, which presumably improves the quality of life (QOL).

Administration, Oral↗
PubMed1999

[Study on CAF + medroxyprogesterone acetate (MPA) therapy for advanced or recurrent breast cancer--comparison between MPA 600 mg and 1,200 mg. Kyushu CAFT Therapy Study Group (Third Study)].

To find the optimal dose of MPA for combined use with CAF therapy for advanced or recurrent breast cancer, a randomized comparative study with a MPA 1,200 mg group and 600 mg group was carried out multi-institutionally. The response rate of complete cases was 37.5% (12/32) in the 1,200 mg group and 36.6% (15/41) in the 600 mg group, showing no difference between the two groups. There were no differences in either the duration of response or the survival term. The major adverse effects and abnormal laboratory test values included alopecia, nausea and vomiting, general fatigue, anorexia and leukopenia, with no difference in incidence between the groups. Moon face, genital hemorrhage and body weight increase, which are thought to be caused by MPA, were found in both groups without a significant difference in incidence. The results of this study revealed no differences in effectiveness or safety between MPA 1,200 mg and 600 mg, suggesting that MPA for combined use with CAF is fully effective at a dose of 600 mg.

Adult↗
PubMed1978

Medroxyprogesterone acetate: peripheral serum levels and its effects on pituitary and ovarian functions in the rhesus monkey.

17 alpha-Acetoxy-6 alpha-methylprogesterone (medroxy-progesterone acetate, MPA) in doses of 50 mg followed 4 weeks later by an additional 100 mg was i.m. injected in 5 adult normal female monkeys. Serum levels of MPA, progesterone, estradiol-17-beta and LH were determined every other day for a period of 8 weeks then weekly for 8 months. Peak values of serum MPA were detected 2 weeks postinjection followed by a gradual decline to undetectable levels after variable periods ranging from 125 to 225 days. The drug, in the doses used, caused inhibition of LH and estradiol surges and suppression of progesterone for more than 6 months. The return of menstrual cyclicity preceded the return of ovulatory cyclicity. Menstrual cyclicity occurred while the drug was still detectable in the blood. The probable site of action of the drug is discussed.

Animals↗