Dataset Information

Effects of continuous versus cyclical oral contraception: a randomized controlled trial.

ABSTRACT: Continuous oral contraception may better suppress the ovary and endometrium, lending itself to the treatment of other medical conditions.Our objective was to determine the effects of continuous vs. cyclical oral contraception.This was a randomized double-blind trial.This trial was performed at an academic medical center in Pennsylvania.A total of 62 healthy women with regular menses were included in the study.Cyclical oral contraception (21-d active/7-d placebo given for six consecutive 28-d cycles) vs. continuous (168-d active pill) therapy using a monophasic pill (20 microg ethinyl estradiol and 1 mg norethindrone acetate) was examined.The primary outcome was vaginal bleeding, and secondary outcomes included hormonal, pelvic ultrasound, quality of life, and safety measures.There was no statistically significant difference in the number of total bleeding days between groups, but moderate/heavy bleeding was significantly greater with the cyclical regimen [mean 11.0 d (sd 8.5) vs. continuous 5.2 d (sd 6.8); P = 0.005], with both groups decreasing over time. Endogenous serum and urinary estrogens measured over six cycles were significantly lower (P = 0.02 and 0.04, respectively) in the continuous group than the cyclical group. Women in the continuous group also had a smaller ovarian volume and lead follicle size over the course of the trial by serial ultrasound examinations. The Moos Menstrual Distress Questionnaire showed that women on continuous therapy had less associated menstrual pain (P = 0.01) and favorable improvements in behavior (P = 0.04) during the premenstrual period.Continuous oral contraception does not result in a reduction of bleeding days over a 168-d period of observation but provides greater suppression of the ovary and endometrium. These effects are associated with improved patient symptomatology.

SUBMITTER: Legro RS

PROVIDER: S-EPMC2243231 | biostudies-literature | 2008 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effects of continuous versus cyclical oral contraception: a randomized controlled trial.

Legro Richard S RS Pauli Jaimey G JG Kunselman Allen R AR Meadows Juliana W JW Kesner James S JS Zaino Richard J RJ Demers Laurence M LM Gnatuk Carol L CL Dodson William C WC

The Journal of clinical endocrinology and metabolism 20071204 2

<h4>Context</h4>Continuous oral contraception may better suppress the ovary and endometrium, lending itself to the treatment of other medical conditions.<h4>Objective</h4>Our objective was to determine the effects of continuous vs. cyclical oral contraception.<h4>Design</h4>This was a randomized double-blind trial.<h4>Setting</h4>This trial was performed at an academic medical center in Pennsylvania.<h4>Patients</h4>A total of 62 healthy women with regular menses were included in the study.<h4>I ...[more]

PMID: 18056769

Similar Datasets

Project description:BackgroundMotor and non-motor impairments affect quality of life in individuals with Parkinson's disease. Our preliminary research indicates that forced exercise cycling, a mode of exercise in which a participant's voluntary rate of exercise is augmented on a stationary cycle, results in global improvements in the cardinal symptoms of Parkinson's disease. The objective of the Cyclical Lower Extremity Exercise (CYCLE) trial for Parkinson's disease is to determine the effects of forced exercise cycling on motor and non-motor performance when compared to voluntary rate cycling and a non-exercise control group. Additionally, we plan to identify any associated changes in neural activity determined by functional magnetic resonance imaging.Methods/designA total of 100 individuals with mild to moderate idiopathic Parkinson's disease will participate in a single-center, parallel-group, rater-blind study. Participants will be randomized 2:2:1 into a forced exercise, voluntary exercise, or no-exercise control group, respectively. Both exercise groups will cycle 3 times per week for 8 weeks at identical aerobic intensities for 40 minutes, but participants in the forced exercise group will cycle 30% faster than their voluntary rate by means of an augmented motorized bicycle. Neuroimaging, clinical, and biomechanical assessments of motor and non-motor performance will be made at baseline both 'on' and 'off' medication, after four weeks of exercise (midpoint), end of treatment, 4 weeks after end of treatment, and 8 weeks after end of treatment.DiscussionCYCLE trial will play a critical role in determining the effectiveness of two different types of aerobic exercise, forced and voluntary, on motor and non-motor performance in individuals with Parkinson's disease. Additionally, the coupling of clinical, biomechanical, and neuroimaging outcomes has the potential to provide insight into mechanisms underlying change in function as a result of exercise.Trial registrationClinicaltrials.gov registration number NCT01636297.

Project description:BackgroundIntermittent fasting is a time-restricted feeding strategy with proven health benefits, which is based on multiple metabolic and endocrine changes, in several patient populations and healthy participants. In the pediatric intensive care unit (PICU), artificial feeding is usually administered 24 hours a day, although solid evidence supporting this practice is lacking. This discards the potential benefits of fasting in this population. We hypothesize that intermittent nutrition with a focus on an overnight feeding interruption (intermittent fasting), as compared with 24-hour continuous nutrition, is a feasible and safe strategy, with potential benefits, for critically ill children.ObjectiveThe aim of the Continuous versus Intermittent Nutrition in Pediatric Intensive Care randomized controlled trial (RCT) is to investigate a strategy of intermittent nutrition with a focus on an overnight feeding interruption period versus 24-hour nutrition during the first 14 days in the PICU.MethodsThe Continuous versus Intermittent Nutrition in Pediatric Intensive Care study is an investigator-initiated RCT in a tertiary referral PICU. Critically ill children (term newborn to 18 years), expected to stay in the PICU for ≥48 hours, and dependent on artificial nutrition, are eligible for inclusion. This study will randomize critically ill children (n=140) to a continuous versus intermittent nutrition strategy. In both groups, similar daily caloric targets will be prescribed. In the continuous group (control), nutrition will be administered 24 hours a day, with a maximum interruption period of 2 hours. In the intermittent group (intervention), nutrition will be interrupted during an age-dependent overnight fasting period. The study intervention will last until admission day 14, initiation of oral intake, or discharge from the PICU, whichever comes first. The primary outcome is the difference in ketosis between the groups under the condition of noninferiority regarding caloric intake. Secondary outcomes are feeding intolerance; the proportion of severe and resistant hypoglycemic events and severe gastrointestinal complications; and additional observed effects on nutritional intake, circadian rhythm, and clinically relevant outcome measures of the intermittent feeding strategy compared with continuous nutrition.ResultsThe study was approved by the Dutch national ethical review board in February 2020. The first patient was enrolled on May 19, 2020. By May 2022, a total of 132 patients had been included in the study. Recruitment of the last patient is expected in Q3 2022.ConclusionsAlthough intermittent fasting has been proven to have many health benefits in both animal and human studies, the feasibility and safety of this strategy in a PICU setting must be investigated. This RCT will help physicians gain more insight into the feasibility, safety, and potential clinical effects of intermittent feeding with overnight fasting in critically ill children.Trial registrationNetherlands Trial Register NL7877; https://trialsearch.who.int/Trial2.aspx?TrialID=NL7877.International registered report identifier (irrid)DERR1-10.2196/36229.

Dataset Information

Effects of continuous versus cyclical oral contraception: a randomized controlled trial.

Publications

Effects of continuous versus cyclical oral contraception: a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets