PubMed Health⌕ Search

Biomedical subjects

I C Barbosa

Publications and source records attributed to I C Barbosa.

13 recordsLinked to original sources
PubMed2002

A randomized, open-label study of conjugated equine estrogens plus medroxyprogesterone acetate versus tibolone: effects on symptom control, bleeding pattern, lipid profile and tolerability.

OBJECTIVE: To compare the effects of continuous combined conjugated equine estrogens plus medroxyprogesterone acetate (CEE/MPA) with those of tibolone on symptom control, bleeding pattern, lipid profile and tolerability in postmenopausal women. METHODS: This was a randomized, open-label, parallel-group, multicenter study. Generally healthy postmenopausal women with an intact uterus and no contraindications to hormone replacement therapy (HRT) or tibolone were enrolled. Each subject was randomly assigned to receive CEE/MPA 0.625 mg-5.0 mg or tibolone 2.5 mg daily for 13 treatment cycles, each of 28 days. RESULTS: A total of 85 subjects were enrolled and received at least one dose of study medication, of which 76 (89.4%) subjects completed the study (n = 40, CEE/MPA; n = 36, tibolone). The incidence of postmenopausal symptoms decreased significantly over time in both treatment groups, compared with baseline, including significant decreases in the incidence of urogenital and sexual health symptoms. Significant differences in symptom control (other than hot flushes) were observed between treatment groups in a few different cycles for different symptoms, but no consistent or clinically significant trends were observed. No statistically significant differences in the incidence of bleeding were observed between treatment groups after cycle 4. Significant decreases in total cholesterol (5.6%) and low-density lipoprotein (LDL) cholesterol (7.5%) were observed at cycle 13, compared with baseline, in the CEE/MPA group, and significant decreases in high-density lipoprotein (HDL) cholesterol (8.5%) and triglycerides (13.7%) were observed at cycle 13, compared with baseline, in the tibolone group. Significant weight gain was observed at cycle 13 in the tibolone group (3.05 kg), compared with the CEE/MPA group (0.96 kg). The incidences of adverse events were similar in both treatment groups. CONCLUSIONS: Women treated with CEE/MPA or tibolone showed significant improvement of postmenopausal symptoms, including urogenital and sexual health symptoms, and had similar bleeding patterns after four cycles of therapy. CEE/MPA and tibolone each induced a different mix of changes in the lipid profile.

Aged↗
PubMed2001

Carbohydrate metabolism in sickle cell patients using a subdermal implant containing nomegestrol acetate (Uniplant).

Uniplant, a second-generation contraceptive implant, has been demonstrated to promote a significant improvement in the overall well-being of women with sickle cell anemia. It has been suggested that the discrete increase in blood glucose levels observed in Uniplant users could be a contributory factor for clinical improvement. Ten healthy sickle cell patients were enrolled in the study. An oral glucose tolerance test was performed prior to implant insertion and at 1, 6, and 12 months of therapy. Blood glucose and insulin were measured before and at 30, 60, 120, and 180 min after a 75-g glucose load. The glucose and insulin areas under the curves were calculated. Fasting glycosylated hemoglobin was also measured. No significant changes were observed in glycosylated hemoglobin, glucose or insulin. We conclude that Uniplant is a safe contraceptive for sickle cell patients.

Adult↗
PubMed1996

Multicenter clinical trial on the efficacy and acceptability of a single contraceptive implant of nomegestrol acetate, Uniplant.

Uniplant, a single Silastic implant containing nomegestrol acetate, provides contraceptive efficacy for one year. Uniplant use for one year was studied in 1,803 healthy women of reproductive age, enrolled from 10 centers in 9 countries, after informed consent. Implants were placed subdermally either in the upper arm or in the gluteal region. Two-hundred-seventy-six subjects discontinued prior to completing one year of study. Cumulative discontinuation rate at 12 months was 15.72%. Medical reasons for discontinuation were principally menstrual-related. Fifteen pregnancies occurred during the one year study period, resulting in a 12-month net cumulative pregnancy rate of 0.94%. Approximately 56% of subjects using Uniplant had bleeding patterns similar to normal menstruation. Results from this study confirm that Uniplant is an efficient, well tolerated, 12-month contraceptive implant, with the advantage of easier insertion and removal of the single implant compared to other multiple implant methods.

Adult↗
PubMed1996

Evaluation of the endometrial cavity during menopause.

OBJECTIVE: To compare transvaginal sonography (TVS), hysteroscopy and suction curettage in the evaluation of uterine bleeding during the menopause. METHODS: Forty-seven patients who presented with either postmenopausal bleeding (31 cases) or sonographic endometrial abnormalities at menopause (16 cases) were evaluated using TVS, hysteroscopy, and curettage with a Karman curette. RESULTS: When endometrial thickness measured by TVS was < 4 mm, there was no endometrial pathology. However TVS could not differentiate accurately between hyperplasia, polyps or endometrial carcinoma. In these cases, endometrial thickness was invariably greater than 5 mm. CONCLUSIONS: Hysteroscopy proved superior to curettage in the diagnosis of endometrial polyps.

Adult↗
PubMed1996

Temporal relationship between Uniplant insertion and changes in cervical mucus.

This study was undertaken to determine the time required by a single implant containing nomegestrol acetate to affect cervical mucus production and sperm penetration in women. All subjects were investigated and, if necessary, treated for any kind of cervicitis or vaginitis prior to starting cervical mucus study. The subjects had not used hormonal contraception for at least three months prior to investigation. They were counseled to use condoms during this study and also to refrain from intercourse during the period of cervical mucus sampling. Follicular development and endometrial thickness were analyzed by transvaginal sonography. Cervical mucus examination, sperm penetration test, and transvaginal sonography were performed during the control cycle and during the first cycle of Uniplant use. Blood samples were taken for the measurement of estradiol, LH, and progesterone. Cervical mucus and sperm penetration tests were evaluated according to the World Health Organization (WHO) criteria. In the treated cycle, when cervical mucus reached a score of 8-10, Uniplant was inserted, independent of the day of the cycle. Cervical mucus was then collected at 0, 4, 8, 12, 24, 48, and 96 h later until a marked change in volume, consistency, ferning spinnbarkheit, and cellularity was observed. All samples were also used for sperm penetration test. Preovulatory estradiol and LH peak decreased significantly compared to pre-implant insertion. Progesterone levels were within the normal limit. Cervical mucus and sperm penetration tests were not affected by Uniplant in the first 12 h. Twenty-four hours after Uniplant insertion, cervical mucus and sperm penetration tests were affected in 70.6% of the women. Forty-eight hours after implant insertion, the women were affected. Follicular rupture occurred in the majority of the women 48 h after implant insertion. Based on these results, it is possible to conclude that Uniplant can affect estradiol and LH preovulatory peaks and disrupt the process of cervical mucus production and sperm penetration, but it was unable to prevent ovulation when inserted in the preovulatory phase.

Adult↗
PubMed1996

Hysteroscopy and transvaginal sonography in menopausal women receiving hormone replacement therapy.

STUDY OBJECTIVE: To evaluate the endometrial cavity of menopausal women with irregular bleeding while receiving hormone replacement therapy. DESIGN: Comparative evaluation of hysteroscopic and biopsy findings. SETTING: A center for reproductive studies. PATIENTS: Forty-one patients receiving different regimens of hormone replacement therapy. INTERVENTIONS: Hysteroscopy, endometrial biopsy, and transvaginal sonography were performed in all 41 women. In 10 patients, endometrial polyps were removed with the resectoscope. MEASUREMENTS AND MAIN RESULTS: Irregular bleeding during hormone replacement therapy was associated with atrophic endometrium whenever transvaginal sonography showed endometrial thickness to be less than 4 mm. In patients who developed increased endometrial thickness after hormone replacement therapy, hysteroscopy revealed the presence of endometrial polyps in the uterine cavity. Histopathologic examination of excised polyps revealed cystic or adenomatous hyperplasia confined to these lesions. CONCLUSIONS: Endometrial polyps can appear in menopausal women receiving hormone replacement therapy despite the presence of progestins to oppose the action of estrogens.

Atrophy↗
PubMed1995

Effects of an implant of nomegestrol acetate, a 19-nor-progesterone derivative, on thyroid function.

This study was undertaken to assess tri-iodothyronine (T3), thyroxine (T4), thyroid stimulating hormone (TSH), T3 uptake, free T3 and free T4 in nomegestrol acetate implant (Uniplant) users. A total of eighteen volunteers of reproductive age who wanted to avoid conception were enrolled in the study. All subjects were investigated before starting treatment. Blood samples for hormonal analysis were taken prior to insertion of the implant. Thereafter, blood samples were drawn at 3, 6, 12, 18 and 24 months of Uniplant use. All subjects had used non-hormonal contraceptives for at least 6 months prior to insertion of the implant. The results observed in this study showed that there was no significant difference in tri-iodothyronine (T3), thyroxine (T4) and thyroid stimulating hormone (TSH) during two years of Uniplant use. No significant difference was found in free T3 levels during two years of Uniplant use. A significant decrease was observed in T3 uptake (p < 0.05) in month 24 and in free T4 (p < 0.05) in month 3 of Uniplant use. All changes observed in this study were inconsistent and all levels were within the normal range.

Adult↗
PubMed1995

Comparative study on intermittent versus continuous use of a contraceptive pill administered by vaginal route.

A multicenter, international, randomized, comparative trial was conducted to assess the acceptability, efficacy and safety of two different schedules of a contraceptive pill, containing 250 micrograms levonorgestrel and 50 micrograms ethinyl estradiol, administered by the vaginal route. One schedule of daily administration for 21 days with a seven-day interruption to allow withdrawal bleeding was compared to daily administration without interruption for bleeding. A total of 900 women were recruited in three countries, Brazil, Egypt and China; 7,090 women-months of vaginal pill use were recorded (3,364 using the pills intermittently and 3,726 continuously). Four undesired pregnancies occurred, one in Egypt and three in China, all four in women using the pills intermittently. There was a statistically significant difference (p = 0.486) in pregnancy rate between the two groups. There were no other significant differences in discontinuation rates despite marked differences in bleeding patterns, amenorrhea predominating in the continuous use group. Hemoglobin levels increased significantly in the two groups but hematocrit was significantly higher in the continuous use group.

Administration, Intravaginal↗
PubMed1983

Induction of ovulation with clomiphene citrate followed by LH-RH in women.

Luteinizing hormone-releasing hormone (LH-RH) was used to induce ovulation following clomiphene priming to stimulate follicular growth. Ovulation was assumed to have occurred following LH-RH injection when progesterone levels started to rise within 48 h following treatment and LH pretreatment levels were below 8 mIU/ml. Ovulation occurred in eight of 10 patients following the administration of LH-RH and six pregnancies were achieved in the first 4 months of treatment.

Anovulation↗
PubMed1982

Long-lasting ovulation inhibition with a new injectable progestagen ORG-2154.

A new long-acting injectable progestagen was tested in 15 women who volunteered for the study. The occurrence of ovulation was assumed by the elevation of progesterone levels above 2ng/ml following a pre-ovulatory estradiol peak. Following a 200mg injection, ovulation was inhibited in all 15 women for five to ten months. In four subjects the interval between the injection and the first progesterone peak was five months. For eight, the interval was six to eight months. In the other three women, ovulation occurred more than eight months following injection. Bleeding episodes, similar to menstruation, occurred in most patients. Bleeding intervals lasting longer than 45 days occurred in nine subjects but more prolonged amenorrhea lasting longer than 60 days was reported by only five subjects. Blood chemistry which included blood cell counts, cholesterol, glucose, alkaline phosphatase, transaminases, urea nitrogen and creatinine remained within normal limits throughout the treatment.

Adult↗
PubMed1980

Effect of prostaglandin F2 alpha on oviduct contractility in marmoset monkeys.

Prostaglandin F2 alpha (PGF2 alpha) increased oviductal contractility under different hormonal conditions. Changes in the response of the oviduct to PGF2 alpha were observed during the reproductive cycle. The response to PGF2 alpha was reduced during the follicular phase, but it increased markedly following both spontaneous and human chorionic gonadotropin-induced ovulation. During the luteal phase the effect of PGF2 alpha on the oviduct was significantly greater than during the follicular phase. The spontaneous motility of the oviduct also increased significantly following ovulation. This increase in motility occurred when progesterone blood levels reached values higher than 1.5 ng/ml, and it was not suppressed by indomethacin, a potent inhibitor of prostaglandin synthesis.

Animals↗