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PubMedDate not supplied

Relationship between premenstrual symptoms and oral contraceptive use: a controlled study.

Patterns of menstrual cycle-related change were compared in three groups of women differing in their use of oral contraceptives and being matched for age, occupation, and parity. These groups were: a "monophasic group" (n = 35) established on low dose "combined" pills with stable levels of estrogen and progestagen. a "triphasic group" (n = 30) on low dose pills with escalating progestagen dosage, and a "non-pill control group" (n = 57) using nonsteroidal contraceptives. Each woman kept visual analogue ratings of mood, irritability, energy, tension, breast tenderness, bloating, and sexual interest for two or three cycles. Cyclicity was evident in all variables assessed, but the only variable to show a clear difference between groups was breast tenderness; the "monophasic group" showed less premenstrual breast tenderness than the other two groups. The monophasic group also showed a tendency to menstrual rather than premenstrual symptoms. In view of the similarity of timing of most cyclical symptoms in the three groups, it is difficult to attribute such cyclical phenomena to the effects of either ovulation or variation in corpus luteum function. For most subjects, the cyclical changes were relatively mild, and these findings need to be replicated in women suffering from severe premenstrual syndrome. However, alternative explanations need to account for changes in women both taking and not taking oral contraceptives.

Adolescent↗
PubMed2004

Upper-extremity deep venous thrombosis complicating whole-blood donation.

BACKGROUND: Up to 36 percent of blood donors may experience a donation-related complication. Fatigue, bruises, hematomas, and vasovagal reactions comprise the great majority of donor reactions and injuries. Serious complications are rare. CASE REPORT: A 20-year-old female taking the third-generation oral contraceptive desogestrel/ethinyl estradiol and ethinyl estradiol (Mircette) developed bruising and increased pain and swelling of her right arm over a 5-day period after whole-blood donation. She was a first-time donor and the venipuncture was reported as being mildly traumatic. There was no personal or family history of thrombosis. RESULTS: Ultrasound examination of her upper extremity revealed the presence of a deep venous thrombosis that required treatment with enoxaparin sodium for 5 days and warfarin for 6 months. Evaluation for thrombophilia was negative. The only risk factor for thrombosis was use of oral contraceptives. CONCLUSION: Although serious complications from whole-blood donation are rare, they may occur. Deep venous thrombosis should be considered in a donor presenting with increasing pain and swelling after blood donation.

Adult↗
PubMed1987

Multi-centre open study of a triphasic levonorgestrel-ethinyloestradiol combined oral contraceptive ('Trinordiol').

A long-term, multi-centre open study was carried out to evaluate the efficacy, cycle control and side-effects with a triphasic, combined oral contraceptive containing levonorgestrel and ethinyloestradiol ('Trinordiol'). A total of 2517 women completing at least 1 cycle of treatment was followed up at 2 to 3-monthly intervals; the overall number of cycles on treatment was 37,090. During treatment, only 2 pregnancies occurred which were attributable to pill failure. Cycle control was good: cycle irregularities were 9.6% overall, but were most common (19.6%) during the first 3 cycles. Only 3.8% of patients withdrew from the study for this reason. Side-effects were those commonly seen with oral contraceptives, and they produced a drop-out rate of only 13.9%. There were no clinically significant effects on blood pressure or body weight. The results also suggested that 'Trinordiol' has a beneficial effect on pre-existing acne.

Acne Vulgaris↗
PubMed1982

Ultrastructure of cervical mucus and sperm penetration during use of a triphasic oral contraceptive.

Scanning electron microscopy and a capillary tube sperm penetration test were used to study the cervical mucus of women using a triphasic oral contraceptive supplying a varying dosage of estrogen and gestagen during the cycle. The findings were compared with those of healthy women having regular cycles and not using contraception. Generally speaking, the ultrastructure of the cervical mucus was dense during medication, like that found in normal luteal phase. No conspicuous changes occurred with different dosages of estrogen and gestagen. For the control cycles a loose structure of the cervical mucus was found on the days prior to the temperature rise, after which a dense structure was predominant. The sperm penetration of the cervical mucus was low during medication, being less than 6 mm/h. For the controls, a high sperm penetration rate was found on the days prior to the temperature rise, while it was low in the luteal phase. The progestogenic type of cervical mucus produced by the medication at all dosages, probably contributes to contraceptive effect.

Cervix Mucus↗
PubMed1988

Ethinylestradiol and desogestrel, alone or in combination with two doses of estriol. Effects on plasma proteins.

Nineteen fertile women were treated with three differently composed oral contraceptives in a cross-over study and were randomly allocated to begin with one of the three preparations. The tablets contained 0.030 mg ethinylestradiol +0.15 mg desogestrel alone (A) or in combination with either 0.5 mg estriol (B) or 2 mg estriol (C). After two treatment cycles on each preparation, blood samples were obtained and analysed for ceruloplasmin, SHBG, prealbumin, transcortin and thyroxine-binding globulin. No differences were found in the induction of liver protein synthesis. It was concluded that the addition of estriol in doses of 0.5 or 2 mg did not influence the effects induced by ethinylestradiol.

Adolescent↗
PubMed1989

Effects of two triphasic oral contraceptives containing ethinylestradiol plus levonorgestrel or gestodene on blood coagulation and fibrinolysis.

The hemostatic effects of a new triphasic oral contraceptive combination containing ethinylestradiol and the new progestogen gestodene were compared with those of a triphasic combination of ethinylestradiol and levonorgestrel. A total of 19 women who did not use any kind of hormonal contraception 3 months prior to the study were recorded. The following parameters were measured: whole blood clotting time (WBCT), whole blood clot lysis time, fibrinogen, antithrombin III, factors V, VII and VIII. Blood samples were taken before treatment and in cycles 1, 3 and 6. A significant shortening of WBCT was observed in cycle 3 and 6 in both groups and also in cycle 1 in the gestodene group. This may indicate an increased sensitivity for activation of platelets, since the assay appears to be quite sensitive to this process. In the other parameters tested there were no significant changes except for a slight increase in plasma fibrinogen in cycle 1 in the gestodene group.

Adult↗
PubMed1996

A triphasic oral contraceptive pill, CTR-05: clinical efficacy and safety.

OBJECTIVE: The primary objective of this study was to compare the safety, contraceptive efficacy, and menstrual cycle patterns in women using triphasic oral contraceptive pills, namely CTR-05, containing 50/100/150 micrograms desogestrel and 35/30/30 micrograms ethinylestradiol, and Orthonovum777 containing 500/750/1000 micrograms norethindrone and 35/35/35 micrograms ethinylestradiol. METHOD: Forty-six female volunteers, satisfying the selection criteria, were evaluated for six cycles, in an open-label, randomized study. Volunteers using CTR-05 were studied for 13 additional cycles for efficacy and safety. RESULTS: No serious adverse effects were observed in either group. The incidences of other drug-related adverse effects, such as headache and nausea, were transient in both groups. CTR-05 did not lower levels of high density lipoprotein (HDL) cholesterol. This may be attributed to the lower androgenicity of its progestin component, desogestrel. No pregnancies were reported in either group. Clinical and laboratory parameters remained within normal limits in both groups. In the CTR-05 group, the lower dose of ethinylestradiol did not affect the safety, efficacy and acceptability of the product. CONCLUSION: Desogestrel, with little estrogenic activity and only minimal androgenic activity, leads to lipoprotein changes, resulting in a favorable cardiovascular profile, as well as minimal androgen-related effects, such as hirsutism and acne.

Adult↗
PubMed1975

[Gynecological, hematological and metabolic studies during therapy with an estrogen-gestagen combination preparation].

Twenty women after menopause were submitted to substitution treatment with a biphasic hormone combination (Cyclacur¿). Nine of these had undergone hysterectomy + ovarectomy. Through 11 days each of the women was administered a daily dose of 2 mg estradiol-valerianate as estrogen. Subsequently, for another 10 days each was given the identical dose of estrogen plus 0.5 mg DL-norgestrel as gestagen. Upon this followed an intermission of 7 days without any medication. After 1 cycle of placebo, 7 cycles of medication were followed by 1 cycle of placebo again with regular controls. Climacteric signs and symptoms were eliminated entirely. In those women without hysterectomy withdrawal-menorrhagia occurred promptly 2--3 days after discontinuing medication. During the entire period of investigation there was no significant change in serum lipids, blood sugar values, or serum enzyme tests used as parameter of hepatic function. As far as hematology is concerned there was a moderate rise of hematocrit. No change of serum protein-bound iodine was observed.

Alanine Transaminase↗
PubMed2001

Norgestimate. From the laboratory to three clinical indications.

This review of preclinical studies and clinical trials of efficacy and safety examines the relation between structure and function in the norgestimate (NGM) molecule, describes the pharmacologic characteristics of NGM and evaluates clinical experience with NGM in oral contraception (OC), treatment of hyperandrogenism in women and hormonal replacement therapy (HRT). NGM is a progestin of the 19-norsteroid series with an oxime group on C-3. In women, only low serum levels of NGM can be detected for five hours after ingestion. NGM is swiftly converted into its main metabolite, the 17-deacetylated norgestimate (norelgestromin), which carries the progestogenic properties of NGM. The metabolite reaches a mean peak concentration of 3,500 pg/mL 1.5 hours after intake and has a half-life of > 24 hours. The progestogenic potency of NGM and its main metabolite is comparable to that of progesterone. The doses of NGM in OCs effectively inhibit ovulation and control uterine bleeding. In the triphasic NGM/ethinyl estradiol (EE) OC, the total monthly load of progestin is only 4.5 mg. NGM has a low androgenic impact and does not interfere with the positive metabolic actions of estrogens, notably the estrogen-induced increase in high-density lipoprotein levels. OCs with NGM and EE increase the serum concentration of sex hormone binding globulin threefold, augmenting the binding of circulating testosterone and reducing free testosterone levels by 50%. Consequently, OCs with NGM are therapeutic for hyperandrogenic symptoms, such as acne. In a new type of HRT three-day dosing with 17 beta-estradiol (E2) alone is followed by three-day dosing with E2 plus NGM. This regimen treats vasomotor symptoms, protects the endometrium from hyperproliferation and is associated with a favorable lipid profile. NGM is a versatile progestin suitable for medical use from adolescence through the reproductive years to menopause.

Contraceptives, Oral, Sequential↗