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PubMed1981

Inhibition of testosterone metabolism by medrogestone in rat ventral prostate in vivo and in vitro.

Medrogestone (MDG), viz., 6,17-dimethyl-4,6-pregnadiene-3,20-dione (Colprone), a synthetic compound with progestational and antiandrogenic properties was studied for its effect on the conversion of testosterone (T) to 5 alpha-dihydrotestosterone (DHT) and 5 alpha-androstane-3 alpha(beta)-17 beta-diol (Adiol) by ventral prostatic preparations of the rat. MDG, 20 mg/kg b.w./day s.c. for 14 days, inhibited the conversion of T to DHT by ventral prostatic homogenates and cytoplasm and at the same dose and route, but for 28 days, it reduced the conversion of T to DHT by ventral prostatic nuclei and T to Adiol by ventral prostatic cytoplasm and nuclei. MDG, from 1 X 10(-4) to 1 X 0(-5) M final concentration in vitro, induced dose-dependent decreases in the conversions of T to DHT and Adiol by ventral prostatic nuclei.

Androstane-3,17-diol↗
PubMed1994

[Ovulation inhibition with medrogestone administered on the 4th through the 24th day of the cycle].

Medrogestone (M) is a derivative of 17 methylprogesterone (P) used for P insufficiency at oral doses of 5 to 15 mg/day (D). We studied the ability of M to inhibit cyclic pituitary-ovarian activity when given at a dose of 10 mg/d from D4 to D24. Ten healthy Caucasian females, aged from 21 to 33, volunteered for an open 2 consecutive cycle study (cycle 1 = control, cycle 2 = M). At inclusion mean (+/- SD) cycle length was 28.6 +/- 1.9 D. Plasma LH, FSH, E2, P, were measured daily from D10 to D20 and at D22, 24, 26. During cycle 1, every subject showed an ovulatory pattern with mid cycle E2 peak (151-400 pg/ml), LH peak (12-59 mUI/ml) and luteal P rise (9.4-22.8 ng/ml). Under M ovulatory surges were suppressed in each of the 10 subjects and P remained below 0.8 ng/ml. These data show that in addition to its known progestomimetic effect, M is a potent ovulation inhibitor when given from D4 to D24 of the cycle.

Adult↗
PubMed2000

[Parameters of lipid metabolism in postmenopausal women on oral or transdermal hormone replacement with or without progesterone].

OBJECTIVE: Aim of the study was to show different influences of transdermal and oral hormone replacement therapies (conjugated and micronized estrogens) with or without varying dosages of C21-progestogens on serum lipids and lipoproteins. MATERIAL AND METHODS: We report on serum triglycerides, cholesterol, HDL-, LDL-cholesterol, apolipoprotein A 1 and B levels of 80 postmenopausal women, who received hormone replacement therapies for more than one year. RESULTS: All patients showed increasing (non-significant) serum HDL/LDL-cholesterol-ratios. Transdermal estrogen monotherapy also influenced the lipid parameters in a positive way. Apolipoprotein B, cholesterol and LDL-Cholesterol decreased, apolipoprotein A 1 increased. Transdermal replacement therapy combined with C21-progestagens and all oral therapies resulted in HDL-cholesterol increases. Positive changes in lipid parameters were most remarkably in women receiving oral therapies. The addition of 42 mg medrogestone/cycle caused a more significant decrease of cholesterol serum levels than higher dosages of medrogestone did. During subsequent treatment cycles, serum triglycerides showed increasing levels within the reference limits in women receiving conjugated estrogens and medrogeston. CONCLUSIONS: Transdermal and oral hormone replacement therapies with and without C21-progestogens are ideal for hormone replacement therapy in postmenopausal women with normal or minor pathological lipid parameters. The lowest possible medrogestone dose necessary for endometrium protection should be used.

Administration, Cutaneous↗
PubMed2001

Cyclic progestin therapy for the management of mastopathy and mastodynia.

The management of benign diseases of the breast aims to halt the progression of fibrocystic transformation and to eliminate the symptoms of pain and breast tenderness. Progestins can be used for this purpose. In a controlled, randomized, double-blind, parallel-group study we treated 31 women with mastopathy/mastodynia with the progestins medrogestone (10 mg/day) or dydrogesterone (10 mg/day) from day 14 to day 25 for six cycles. Before, during and at the end of therapy the following parameters were evaluated: subjective symptoms (pain, tenderness, impairment of daily activities), palpatory findings, sonographic diagnosis and sex hormone profiles. Cyclic administration of the low-dose progestins medrogestone and dydrogesterone proved to be an effective and safe treatment of mastodynia and mastopathy. The objective parameters palpatory findings and sonographic imaging of breast nodules and cysts improved in more than 50% of patients. Improvement was particularly marked in women with low progesterone levels in the second half of the cycle. After six treatment cycles, 75% of the patients treated with dydrogesterone and 86% of the patients treated with medrogestone were completely pain-free.

Adult↗
PubMed1993

A new peroral estrogen/progestin combination for postmenopausal hormonal substitution: an open multicentric field study.

An open prospective multicentric trial has been conducted over 6 months in 241 postmenopausal volunteers. One-hundred forty-one women had an intact uterus. All patients received a fixed peroral combination of conjugated estrogens CE (1.25 mg per day from day 1 to day 21) and medrogestone (5 mg per day from day 12 to day 21) followed by 7 days without substitution (day 22 to day 28). After 3 months of treatment, the managing physician could, according to the patient's clinical response, reduce the dosage of CE to 0.625 mg daily. This dose reduction took place in 79 patients (38.9%). The trial was designed to study efficacy, compliance and side-effects of this combination. Of the patients 68.9% showed a very good, 27.7% a good and 1.9% a satisfactory improvement of their preexisting subjective complaints. Of the patients 28.6% suffered from minor side-effects leading to drop-outs in 7.8% of the cases. Of the women participating in the study 92.2% completed the trial without from the treatment scheme. No serious complications have been noted. After 6 months of treatment, a regular bleeding pattern has been observed in 71.5% of the 144 non-hysterectomized women, an irregular pattern in 9.7% and amenorrhoea in 18.8%. Total cholesterol showed no change, whereas HDL rose significantly from 1.58 to 1.72 mmol/l (P < 0.01) resulting in a drop of Total-Cholesterol-HDL-Ratio of -8.8% (P < 0.01). LDL decreased from 3.71 +/- 1.56 to 3.45 +/- 1.39 (P < 0.05). Considering the two patient groups with and without estrogen reduction after 3 months, HDL increase was significant in both groups but was dose dependent. The HDL increase compared to the initial value was 5.7% with 0.625 mg CE and +10.8% with 1.25 mg CE, respectively. The fixed peroral combination of CE and medrogestone tested was effective, easy to administer and safe. The bleeding pattern observed was mostly regular. The pattern of serum lipids changed favorably in a significant way. Therefore, the use of this new peroral estrogen/progestin combination can be recommended for routine substitution in postmenopausal women.

Blood Pressure↗
PubMed2002

Effect of tibolone compared with sequential hormone replacement therapy on carbohydrate metabolism in postmenopausal women.

OBJECTIVE: To investigate the effects of tibolone on carbohydrate metabolism, and to compare these effects with those of a sequential regimen of conjugated equine estrogens and medrogestone. METHODS: This was an open-label, multicentre, comparative study. Seventy-two postmenopausal women were randomized to receive either tibolone 2.5 mg/day or conjugated equine estrogens 0.6 mg plus sequential medrogestone 5 mg (CEE/M) for six 28-day cycles. Carbohydrate metabolism was evaluated at baseline and after three and six cycles of treatment by an oral glucose tolerance test (OGTT). A blood sample was taken at 30, 60, 90 and 120 mm after glucose 75 mg dosing for determination of plasma glucose, insulin and connecting peptide (C-peptide) levels. RESULTS: The changes from baseline of glucose, insulin and C-peptide area-under-the-curve (AUC) values were not statistically significant after 3 and 6 months of tibolone or CEE/M treatment. There was a small transitory decrease in HbA(1C) after three cycles of treatment with tibolone. CONCLUSION: The effects of tibolone and CEE/M on carbohydrate metabolism were considered to have no clinical significance.

Blood Glucose↗
PubMed1997

Bone effects of transdermal hormone replacement therapy in postmenopausal women as evaluated by means of ultrasound: an open one-year prospective study.

OBJECTIVES: To evaluate the effectiveness of transdermal oestrogen replacement therapy plus medrogestone (HRT) in postmenopausal bone loss prevention by means of US. METHODS: We enrolled 112 healthy postmenopausal women in an open, prospective study. These women, after a gynaecological evaluation and an US assessment of the skeletal status, were advised to take cyclic sequential oestrogen/progestagen therapy: 50 microg/day of transdermal 17beta-oestradiol (Rotta Research Laboratorium) plus 5 mg/day of medrogestone, for 12 days per cycle (Wyeth-Ayerst). After 1 year we recalled these women: only 32 of them were taking HRT, while 49 had declined HRT without taking alternative therapies. The remaining women were excluded from the study as they were either unavailable for the check-up or they were taking prohibited therapies. We used DBM Sonic 1200 (Igea, Italy) to assess US parameter changes at phalanxes at enrollment and after 1 year. This device enabled us to evaluate US transmission velocity (AD-SoS) and US attenuation pattern (UBPS). In a previous study we had evaluated the intra- and inter-observer reproducibility of AD-SoS measurements (0.4 and 1.0% respectively). Using the same data we evaluated the intra- and inter-observer precision of UBPS. RESULTS: The UBPS intra-operator reproducibilities were 5.3% and 6.1% (for the 1st and the 2nd operator, respectively), while inter-observer precision was 8.8%. Both AD-SoS and UBPS significantly decreased in the non-user group(-0.7%, P < 0.001 and -14.3%, P < 0.001 respectively). In the user group AD-SoS showed a significant increase (+0.7%, P < 0.01), while a slight but significant decrease was observed for UBPS (-2.8%, P < 0.05). CONCLUSIONS: Our findings show that the effectiveness of transdermal HRT in slowing or even arresting postmenopausal bone loss can be monitored by quantitative US studies. The trend difference observed between AD-SoS and UBPS with and without therapy is at least partially explained by a different response to HRT with regard to bone density as well as structure.

Administration, Cutaneous↗
PubMed1998

Ultrasonographic measurement of endometrial thickness during hormonal replacement therapy in postmenopausal women.

The objective of this study was to measure endometrial thickness by transvaginal ultrasonography during two regimens of hormonal replacement therapy (HRT) in postmenopausal women and to compare these data with endometrial histology. Transvaginal ultrasonographic evaluation of endometrial thickness and endometrial biopsy were performed in 80 postmenopausal women before and after 6 months of HRT (between the 24th and the 28th day of the cycle). The group was randomized so that 40 women (Group A) were treated with a continuous sequential regimen consisting of 5 micrograms/day of estradiol continuously and 5 mg/day of medrogestone from the 17th to the 28th day of the cycle; and 40 women (Group B) were given continuous administration of 50 micrograms/day estradiol and 5 mg/day medrogestone. Prior to therapy, there was no significant difference in mean endometrial thickness between the groups. After 6 months of therapy, endometrial thickness was significantly increased in comparison with basal values in both groups. The mean value was significantly higher (p < 0.001) in Group A (8.5 +/- 3.7 mm) than in Group B (3.6 +/- 1.3 mm). In Group A, endometrial thickness was < or = 4 mm in 16.7% of patients and < or = 8 mm in 69.5% of patients. In Group B, 91% of patients had an endometrium of < or = 4 mm. In both groups, the thickness of the atrophic endometrium was less than that of the other histological types of endometrium (4.1 +/- 0.3 mm for Group A and 3.5 +/- 1.2 mm for Group B). In Group A, the difference in mean endometrial thickness between the proliferative and secretory endometrium was not statistically significant. In both groups, the transvaginal ultrasonographic measurement of endometrial thickness of < or = 4 mm had a high sensitivity for detecting atrophic endometrium (83.3% for Group A and 93.7% for Group B).

Biopsy, Needle↗
PubMed1999

Blood flow in the internal carotid and middle cerebral arteries: effects of continuous oral conjugated equine estrogens administration with monthly progestogen supplementation on postmenopausal women.

OBJECTIVE: This study was designed in order to evaluate the effect of conjugated equine estrogens (CEE) on internal carotid and middle cerebral artery blood flow in postmenopausal women. DESIGN: Thirty-four healthy postmenopausal women with intact uteri were randomly divided into two groups of 17 subjects each. The first group was treated for 24 weeks with continuous CEE medication (0.625 mg daily) and cyclical supplementations of 5 mg/day of medrogestone acetate, given on the last 12 days of every 4-week period (Prempak, Wyeth, Italy). The second group received no treatment. The pulsatility indices (PI) of both the internal carotid artery and middle cerebral artery were measured. RESULTS: In the treated group, the PI of the interior carotid artery and MCA was reduced from respectively 0.736 (0.016) and 0.745 (0.009) at baseline, to 0.669 (0.021) and 0.670 (0.011) after 24 weeks (p = 0.01); in the control group, the PI values remained unchanged. The between-group difference for both arteries was significant (p < 0.01). CONCLUSIONS: The administration of CEE with cyclical medrogestone supplementation to postmenopausal women induces a statistically significant reduction in the PI of cerebral arteries.

Administration, Oral↗
PubMed1978

Interference of gestagens and androgens with rat uterine oestrogen receptors.

The inhibitory effect of some gestagens and calusterone on the binding of oestradiol-17beta to its specific uterine receptors has been investigated in intact rats. Progesterone, medrogestone, clogestone, medroxyprogesterone acetate and calusterone reduce the specific oestradiol-receptor interaction in vitro; this effect is dose-dependent and does not differ significantly from one drug to the other. A more relevant decrease in the amount of oestradiol-17beta bound to specific receptors has been observed with calusterone. Progesterone, clogestone, medrogestone, medroxyprogesterone acetate and calusterone given orally induce a marked decrease (between 30 and 70% depending on the dose) in the binding capacity of oestradiol-17beta to specific uterine receptors in vivo. Results from a Scatchard plot analysis suggest that the interference with the binding of oestradiol-17beta caused by both progestogens and calusterone is due to a non-competitive interaction.

Animals↗
PubMed1975

Steroid-protein interactions. Stopped flow fluorescence studies of the interaction between steroid hormones and progesterone-binding globulin.

Stopped flow fluorometry, measuring changes in the intrinsic fluorescence of progesterone-binding globulin (PBG), was used to determine the association and dissociation rates of the interaction of PBG with seven delta4-3-ketosteroids. The rates of formation and dissociation of the PBG-progesterone complex were measured as a function of concentration and temperature. At 20 degrees, kon = 8.7 X 10(7) M-1 S-1 and koff = 0.060 S-1. The association rate constants for progesterone, deoxycorticosterone, testosterone, testosterone acetate, and medrogestone were found to be the same within experimental error. The different affinities of PBG for these steroids result from the dissociation rate constants of the steroids which ranged from 0.43 S-1 for testosterone to 0.024 S-1 for medrogestone. Two corticosteroids, corticosterone and cortisol, were both bound somewhat more slowly (approximately 5 X 10(7) M-1 S-1). Reflecting their very low affinity for PBG both steroids dissociate very rapidly: corticosterone at 1.4 S-1 and cortisol at 90 S-1. The ratio of association to dissociation rate constants gave affinity constants in agreement with independently determined constants.

Animals↗