estradiol-valerate-dienogest and Pelvic-Pain

The menstrual cycle is characterised by cyclical fluctuations in oestrogens, progesterone and androgens. Changes in hormone levels in the premenstrual phase with the decline in progesterone trigger a physiological reaction which culminates in menstruation. This process is accompanied in many women by various symptoms such as pelvic pain, headache, mood disorders and gastrointestinal discomfort. The aim of this article was to summarise the latest findings on the physiology and pathophysiology of menstruation and review the impact of shortening the hormone-free interval (HFI) on the health and wellbeing of women.. Menstruation can be viewed as an inflammatory event in which local and systemic effects produce symptoms in genital and extragenital regions of the body. The mast cells are the main mediator of this reaction. In women using hormonal contraceptives, menstrual bleeding is not biologically necessary and it may be advantageous to maintain more stable levels of oestrogens, progesterone and androgens throughout the cycle. New combined oral contraceptives (COCs) have been formulated with a progressively shorter HFI (24/4 and 26/2) than traditional 21/7 pills, with the rationale of reducing hormone withdrawal- associated symptoms. Several studies have shown the beneficial effects of these regimens, which reduce the inflammatory exposure of the female organism and thus have the capacity to increase the quality of life of women. A combination of estradiol valerate (E2V) and dienogest (DNG) is administered on the shortest 26/2 regimen. This regimen has a broad evidence base from randomised controlled trials that have examined the impact of E2V/DNG on symptoms and quality of life.. Shortening the HFI reduces the occurrence of bleeding-related inflammatory processes and subsequent physical and mental symptoms. The shortest interval with evidence of reproductive and sexual health benefits is provided by a 26/2 regimen.

Topics: Contraceptives, Oral, Combined; Contraceptives, Oral, Hormonal; Drug Administration Schedule; Drug Combinations; Dysmenorrhea; Estradiol; Estrogens; Female; Gastrointestinal Diseases; Headache; Humans; Inflammation; Menstruation; Mood Disorders; Nandrolone; Pelvic Pain; Progesterone; Quality of Life

Pain relief of two different oral contraceptive pills (OCPs) in severe primary dysmenorrhoea (PD) was compared. Sixty-six nulliparous patients with severe PD requiring contraception were evaluated. Group 1 comprised 33 healthy controls. Patients with severe PD were divided into two groups. Patients in Group 2 were administered oestradiol valerate/dienogest and patients in Group 3 were administered ethinylestradiol/drospirenone. Doppler indices of both uterine arteries (left and right) including systolic/diastolicrates (S/D), pulsatility index (PI) and resistance index (RI) were measured, and a visual analogue scale (VAS) was applied to patients before treatment. VAS scores and Doppler indices were repeated after 3 months of OCP treatment and the changes in values were compared. The demographic and clinical characteristics of the patients were similar. The mean value of RI was significantly lower after therapy in Groups 2 and 3 in the right and left uterine arteries (p = .001 and p = .039, respectively). The clinical trial number was NCT03124524. Impact Statement What is already known on this subject: OCPs are the most appropriate treatment option for PD. There is no clear data about OCP containing dienogest for treatment in PD. Dienogest has been reported to be highly effective in the treatment of endometriosis and is also recommended as first-line therapy for pelvic pain-associated endometriosis. What the results of this study add: In this study, although there was no superiority in pain relief between the treatment groups, lower VAS scores and lower RI values of uterine arteries were seen after treatment. Both OCPs relieve pain in severe PD. There was no serious adverse effect in the patients. What the implications are of these findings for clinical practice and/or further research: Estradiol valerate/dienogest, which is a routinely prescribed drug for heavy menstrual bleeding in women who desire oral contraception, is as effective as ethinylestradiol/drospirenone in pain relief.

Topics: Adolescent; Adult; Androstenes; Contraceptives, Oral; Drug Combinations; Dysmenorrhea; Estradiol; Ethinyl Estradiol; Female; Humans; Nandrolone; Pain Measurement; Pelvic Pain; Prospective Studies; Pulsatile Flow; Treatment Outcome; Ultrasonography, Doppler; Uterine Artery; Young Adult

To evaluate the efficacy of dienogest + estradiol valerate (E2V) and gonadotrophin-releasing hormone analogue (GnRH-a) in reducing recurrence of pain in patients with chronic pelvic pain due to laparoscopically diagnosed and treated endometriosis.. Multi-center, prospective, randomized study.. Three university departments of obstetrics and gynecology in Italy.. Seventy-eight women who underwent laparoscopic surgery for endometriosis combined with chronic pelvic pain.. Post-operative administration of dienogest + E2V for 9 months (group 1) or GnRH-a monthly for 6 months (group 2).. A visual analogue scale was used to test intensity of pain before laparoscopic surgery at 3, 6 and 9 months of follow up. A questionnaire to investigate quality of life was administered before surgery and at 9 months of follow up.. The visual analogue scale score did not show any significant differences between the two groups (p = 0.417). The questionnaire showed an increase of scores for all women compared with pre-surgery values, demonstrating a marked improvement in quality of life and health-related satisfaction with both treatments. No significant differences were found between the groups. The rate of apparent endometriosis recurrence was 10.8% in group 1 and 13.7% in group 2 (p = 0.962).. Both therapies seemed equally efficacious in preventing endometriosis-related chronic pelvic pain recurrence in the first 9 months of follow-up.

Topics: Adolescent; Adult; Drug Combinations; Endometriosis; Estradiol; Female; Gonadotropin-Releasing Hormone; Humans; Italy; Laparoscopy; Middle Aged; Nandrolone; Pain Management; Pain Measurement; Pelvic Pain; Prospective Studies; Quality of Life; Recurrence; Surveys and Questionnaires

To determine the effect of oestradiol valerate/dienogest (E2V/DNG) versus ethinylestradiol/norgestimate (EE/NGM) on hormone-withdrawal associated symptoms (HWAS) in otherwise healthy women who had experienced at least one of these symptoms when using 21/7-day combined oral contraceptives (COCs).. This phase III, parallel-group study randomised 409 women aged 18 to 50 years to E2V/DNG or EE/NGM. The primary efficacy variable was the change from baseline to cycle 6 in the average of the three highest visual analogue scale values for headache and/or pelvic pain during cycle days 22 to 28.. In total, 395 were included in the full analysis set (E2V/DNG, n = 191; EE/NGM, n = 204). E2V/DNG reduced the symptoms of headache or pelvic pain during cycle days 22 to 28 from baseline to cycle 6 to a significantly greater extent than EE/NGM (mean decrease 43.6 vs. 35.5 mm; p = 0.0024). Both treatments were well tolerated with a similar proportion of women experiencing adverse events that were considered at least possibly related to treatment (35% E2V/DNG vs. 34% EE/NGM).. E2V/DNG reduces the frequency and intensity of headache and pelvic pain to a greater extent than EE/NGM, and may be a good option for women susceptible to HWAS with conventional 21/7-day COCs.

Topics: Adult; Contraceptives, Oral; Double-Blind Method; Drug Combinations; Estradiol; Ethinyl Estradiol; Female; Headache; Humans; Menstruation; Nandrolone; Norgestrel; Pelvic Pain; Substance Withdrawal Syndrome; Treatment Outcome; Young Adult

The progestin dienogest (DNG) given alone effectively reduces pelvic pain of women with endometriosis. It is not clear whether the same occurs when DNG is associated with estradiol (E2).. Patient preference prospective observational study.. Outpatient centre of university hospital.. 40 patients with endometriosis and menstrual pain.. 24-week treatment with a quadriphasic association of E2 valerate (E2V) and DNG or a nonsteroidal anti-inflammatory drug (NSAID) to be used only in case of pain (ketoprofene 200-mg tablets).. Menstrual pain and, when present, intermenstrual pain, and dyspareunia were investigated by means of a 10-cm visual analogue scale (VAS). Quality of life was investigated by the short form 36 (SF-36) of the health-related quality of life questionnaire.. Final study group consists of 34 patients, 19 in the E2V/DNG group and 15 in the NSAID group. After 24 weeks, no significant modification of menstrual pain, intermenstrual pain, dyspareunia, or SF-36 score was observed in the NSAID group. Treatment with E2V/DNG reduced the VAS score of menstrual pain by 61% (P < .0001). In the subgroups of women with intermenstrual pain or dyspareunia, E2V/DNG reduced these complaints by 65% (P = .013) and 52% (P = .016), respectively. The reduction in menstrual (P = .0001) and intermenstrual pain (p = 0.03) was significantly greater during E2V/DNG than NSAID. Quality of life improved during E2V/DNG (P = .0002), both in physical (P = .0003) and mental domains (P = .0065). Only a few minor adverse effects were described during E2V/DNG, and none caused withdrawal from treatment.. In patients with endometriosis and pelvic pain, the 24-week administration of the quadriphasic association of E2V/DNG decreases pelvic pain and improves quality of life.

Topics: Adult; Contraceptives, Oral, Hormonal; Drug Combinations; Dysmenorrhea; Endometriosis; Estradiol; Female; Hospitals, University; Humans; Italy; Nandrolone; Pain Measurement; Patient Preference; Pelvic Pain; Pilot Projects; Prospective Studies; Quality of Life; Surveys and Questionnaires; Time Factors; Treatment Outcome

In recent years, both dienogest, a fourth-generation progestin, and levonorgestrel-releasing intrauterine device have been found to be effective in terms of endometriosis-related pelvic pain improvement. No data, however, are available about their efficacy in terms of postoperative recurrence prevention in women recently submitted to surgery for endometriosis at every stage. Our objective was to compare two postoperative medical approaches for pain control and reduction of recurrences in patients undergoing surgery for endometriosis.. Ninety-two patients undergoing surgery for endometriosis and subsequent treatment by estradiol valerate + dienogest (EP) (group A) or levonorgestrel-releasing uterine device (LNG-IUD) (Group B) between January 2009 and June 2010 were retrospectively analyzed. The primary endpoints were pain relapse and disease recurrence rate at 12 and 24 months. The secondary endpoint was patient satisfaction with the therapy at 24 months.. Forty-eight patients in Group A and 44 in Group B were examined. At 12 and 24 months a statistically greater reduction both in Ca125 levels and VAS score was seen in women treated with EP compared to LNG-IUD. The recurrence rate at 12 and 24 months follow-up was slightly lower, but not at a significant level, in Group A than in Group B. Finally, satisfaction with treatment at 24 months was significantly higher in Group B.. EP administration is significantly more effective than LNG-IUD in reducing pelvic pain and more effective in reducing recurrence rate but not at a significant level. LNG-IUD, however, has significantly higher patient satisfaction.

Topics: Adult; Combined Modality Therapy; Contraceptive Agents, Female; Drug Combinations; Endometriosis; Estradiol; Estrogens; Female; Follow-Up Studies; Humans; Intrauterine Devices, Medicated; Levonorgestrel; Nandrolone; Patient Satisfaction; Pelvic Pain; Postoperative Care; Receptors, Progesterone; Retrospective Studies; Secondary Prevention