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Oral Contraceptive Side Effect Management

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1. Oral Contraceptive Side Effect Management

Oral Contraceptive Side Effect Management Oral Contraceptive Side Effect Management Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 (...) Oral Contraceptive Side Effect Management Oral Contraceptive Side Effect Management Aka: Oral Contraceptive Side Effect Management II. Management: Nausea Take pill at bedtime, or at a meal Use Low pill (e.g. ) III. Management: Fluid Retention Change to OCP with the following characteristics Low (or low dose) Examples IV. Management: Appetite too active or weight gain Change to OCP with the following characteristics Low (or low dose) Low Examples V. Management: Hypertension Discontinue Consider

2018 FP Notebook

2. Fingolimod (Gilenya): increased risk of congenital malformations; new contraindication during pregnancy and in women of childbearing potential not using effective contraception

with the general population (a two-fold increase) fingolimod is contraindicated during pregnancy and in women of childbearing potential not using effective contraception Management of women of childbearing potential before and during fingolimod treatment advise women that fingolimod increases the risk of congenital abnormalities and provide them with the new pregnancy-specific patient reminder card exclude pregnancy before starting fingolimod and repeat pregnancy testing at suitable intervals during treatment (...) (depending on contraceptive used and personal circumstance – see guidance below) ensure that an effective form of contraception is used during treatment and for 2 months after discontinuation stop fingolimod 2 months before a pregnancy is planned and consider alternative treatments Management if pregnancy exposed should a woman on fingolimod become pregnant, stop treatment immediately and refer to an obstetrician for close monitoring during pregnancy, including ultrasound assessments exposed pregnancies

2019 MHRA Drug Safety Update

3. Are the Combined Oral Contraceptive Pills Needed for Management of the Simple Ovarian Cysts in Reproductive Women?

about how to take oral contraception and informed of possible side effects. They also will receive a diary card for recording oral contraception intake to be returned to the physician on the next period. An appointment for the women in this group will be scheduled at one month of treatment for the second ultra-sonography. If the ovarian cyst does not show remission, the women will continue the same treatment and will follow up in another month by transvaginal ultra-sound. If the ovarian cyst still (...) to evaluate the size and location of the functional ovarian cyst (follicular), to compare the effect of different modalities of management whether remission, regression, progression or persistence of functional ovarian cyst. The women will be assigned randomly to either study group to take oral contraceptive pills or to control group to take placebo. The 2 groups will be treated and followed up equally. Oral contraceptive pills will be given to the study group as follow: The women will receive one package

2017 Clinical Trials

4. Canadian Contraception Consensus Part 4 of 4 Chapter 9: Combined Hormonal Contraception

oral contraceptives. Figure 2 Missed contraceptive patch. Figure 3 Missed contraceptive ring. Appendix C Abstract Objective To provide guidelines for health care providers on the use of contraceptive methods to prevent pregnancy and on the promotion of healthy sexuality. Outcomes Overall efficacy of cited contraceptive methods, assessing reduction in pregnancy rate, safety, and side effects; the effect of cited contraceptive methods on sexual health and general well-being; and the availability (...) the criteria described in the Report of the Canadian Task Force on Preventive Health Care. Recommendations for practice are ranked according to the method described in this report. Summary Statements 1. Although highly effective with perfect use, typical use failure rates for combined hormonal contraceptives, including the combined oral contraceptive pill, are as high as 9% (II-2). 2. The majority of qualified studies do not indicate decreased combined oral contraceptive pill efficacy in obese women

2017 Society of Obstetricians and Gynaecologists of Canada

5. Canadian Contraception Consensus Part 4 of 4 Chapter 9: Combined Hormonal Contraception

as a subscribed user or . Click to view the full text on ScienceDirect. Figures Figure 1 Missed combined oral contraceptives. Figure 2 Missed contraceptive patch. Figure 3 Missed contraceptive ring. Appendix C Abstract Objective To provide guidelines for health care providers on the use of contraceptive methods to prevent pregnancy and on the promotion of healthy sexuality. Outcomes Overall efficacy of cited contraceptive methods, assessing reduction in pregnancy rate, safety, and side effects; the effect (...) planning organizations were also reviewed. Values The quality of the evidence is rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care. Recommendations for practice are ranked according to the method described in this report. Summary Statements 1. Although highly effective with perfect use, typical use failure rates for combined hormonal contraceptives, including the combined oral contraceptive pill, are as high as 9% (II-2). 2. The majority of qualified

2017 Society of Obstetricians and Gynaecologists of Canada

6. Comparing the Effects of Oral Contraceptive Pills Versus Metformin

Comparing the Effects of Oral Contraceptive Pills Versus Metformin Comparing the Effects of Oral Contraceptive Pills Versus Metformin - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Comparing the Effects (...) is planned. Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment Official Title: Comparing the Effects of Oral Contraceptive Pills Versus Metformin in the Medical Management of Overweight/Obese Women With Polycystic Ovary Syndrome Actual Study Start Date : January 1, 2018 Estimated Primary Completion Date : April 30, 2021 Estimated Study Completion Date : April 30, 2022 Resource links provided by the National Library of Medicine related topics: related topics: available

2017 Clinical Trials

7. Comparison of combined hormonal vaginal ring with ultralow-dose combined oral contraceptive pills in the management of heavy menstrual bleeding: A pilot study. (PubMed)

Comparison of combined hormonal vaginal ring with ultralow-dose combined oral contraceptive pills in the management of heavy menstrual bleeding: A pilot study. The aim of this study was to compare combined hormonal vaginal ring with ultralow-dose combined oral contraceptive (COC) pills in management of heavy menstrual bleeding (HMB). Fifty patients were randomised into Group I: vaginal ring (n = 25) and group II: COC pills (n = 25). Menstrual blood loss (MBL) was assessed at baseline, 1, 3 (...) , respectively (p = 0.001). Reduction in MBL with ring was greater at higher baseline PBAC score but lesser in patients with fibroid > 2 cm. Combined vaginal hormonal treatment for HMB is as effective as oral hormonal therapy, with minor and transient side effects and persistence of response after cessation of therapy.

2016 Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology

8. The Effect of Oral Contraceptives on Women Balance

The Effect of Oral Contraceptives on Women Balance The Effect of Oral Contraceptives on Women Balance - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. The Effect of Oral Contraceptives on Women Balance (...) Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Diagnostic Official Title: The Effect of Oral Contraceptives on Dynamic Balance in Women Study Start Date : January 2015 Actual Primary Completion Date : July 2016 Actual Study Completion Date : July 2016 Resource links provided by the National Library of Medicine available for: Arms and Interventions Go to Arm Intervention/treatment Active Comparator: Oral contraceptive pills users The participants

2016 Clinical Trials

9. A Study of Lanabecestat in Healthy Female Participants Taking Oral Contraceptive

Posted : June 28, 2018 Sponsor: Eli Lilly and Company Collaborator: AstraZeneca Information provided by (Responsible Party): Eli Lilly and Company Study Details Study Description Go to Brief Summary: The study will evaluate the effect of oral contraceptive (birth control pill) on the blood level of lanabecestat when both are given together. Side effects will be monitored and documented. This study will last up to 27 days for each participant, not including screening. Screening is required within 42 (...) A Study of Lanabecestat in Healthy Female Participants Taking Oral Contraceptive A Study of Lanabecestat in Healthy Female Participants Taking Oral Contraceptive - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding

2018 Clinical Trials

10. Oral Contraceptive Side Effect Management

Oral Contraceptive Side Effect Management Oral Contraceptive Side Effect Management Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 (...) Oral Contraceptive Side Effect Management Oral Contraceptive Side Effect Management Aka: Oral Contraceptive Side Effect Management II. Management: Nausea Take pill at bedtime, or at a meal Use Low pill (e.g. ) III. Management: Fluid Retention Change to OCP with the following characteristics Low (or low dose) Examples IV. Management: Appetite too active or weight gain Change to OCP with the following characteristics Low (or low dose) Low Examples V. Management: Hypertension Discontinue Consider

2015 FP Notebook

11. Overweight, Obesity and Contraception

Health benefits of POP 17 5.5 Combined hormonal contraception (CHC) 17 5.5.1 CHC effectiveness 17 5.5.2 CHC safety 20 5.5.3 Weight gain with CHC 22 5.5.4 Health benefits of CHC 22 5.6 Barrier methods of contraception 22 5.6.1 Barrier method effectiveness 22 5.6.2 Barrier method safety 22 5.7 Fertility awareness methods 23 5.8 Emergency contraception (EC) 23 5.8.1 Cu-IUD 23 5.8.2 Oral EC 23 5.9 Female surgical sterilisation 25 5.9.1 Effectiveness and safety 25 6 Contraception and weight management (...) Healthcare 2019 FSRH guideline: Overweight, Obesity and Contraception Contraception and weight management treatment Weight-loss medication and contraception Clinical recommendation ü Women should be advised that it is possible that medications that induce diarrhoea and/or vomiting (e.g. orlistat, laxatives) could reduce the effectiveness of POP, COC and oral EC. Weight-loss surgery and contraception Key information D Non-oral contraceptives have been studied in only small numbers of women following

2019 Faculty of Sexual & Reproductive Healthcare

12. RCN position statement: The role of school nurses in providing emergency contraception services in education settings

have a lower failure rate than Levonelle 1500. It should be noted that available evidence suggests that oral emergency contraception administered after ovulation is ineffective (FSRH, 2017), Dixon (2016). Considerations School Nurses providing emergency contraception should recommend a barrier method of contraceptive as oral emergency contraceptives are likely to inhibit the effects of regular hormonal contraceptives for up to 16 days, (Hopkins 2014; FSRH, 2017). Consideration should also been (...) or procedure (see www.hpw.wales.gov.uk). There are several important issues for school nurses to consider when they are consulted by young people under 16 years of age about emergency contraceptives (Department of Health, 2004). School nurses: • must ensure that the young person understands the potential risks, benefits and alternatives of the treatment including efficacy, adverse effects, interactions, the need for additional contraceptive precautions and advice given • are legally obliged to discuss

2018 Royal College of Nursing

13. Contraceptive Choices for Young People

of factors: effectiveness, discreetness, safety, side effect profile, invasiveness, knowledge of the method, ease of use or how difficult it is to forget. 33 4.2 Non-adherence and discontinuation For all women, typical failure rates with use of combined oral contraception (COC) and male condoms are as high as 8% and 15%, respectively, in the first year of use. 34 A survey in the USA showed that women aged under 20 years experienced a contraceptive failure rate of about 16% in the first 12 months of use (...) of combined hormonal contraception (CHC) methods and progestogen- only methods. 2,3 Studies looking at COC have generally found no difference between pill users and non- users. 81,82 One study found that although two-thirds or young women aged 14–19 years anticipated mood changes with COC use, only 9% experienced such symptoms. 83 A randomised controlled trial of young women aged under 19 years experiencing dysmenorrhoea found similar numbers and types of oral contraceptive side effects, including

2019 Faculty of Sexual & Reproductive Healthcare

14. Ovulation Incidence in Oral Contraceptive Users

containing either higher doses of estrogen or progestin alone. It is not known whether EE 10mcg is sufficient to prevent follicular development or to support the endometrium as well as higher doses of EE. This trial addresses the question of whether an oral contraceptive pill with EE 10mcg/Norethindrone acetate 1mg will better suppress ovulation or have a better side effect profile than a progestin only pill with a nearly equal dose of norethindrone. Condition or disease Intervention/treatment Phase (...) Ovulation Incidence in Oral Contraceptive Users Ovulation Incidence in Oral Contraceptive Users - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Ovulation Incidence in Oral Contraceptive Users The safety

2017 Clinical Trials

15. Non-contraceptive oestrogen-containing preparations for controlling symptoms of premenstrual syndrome. (PubMed)

neuroendocrine anomaly.Transdermal oestradiol by patch, gel or implant effectively stops ovulation and the cyclical hormonal changes which produce the cyclical symptoms. These preparations are normally used for hormone therapy and contain lower doses of oestrogen than found in oral contraceptive pills. A shortened seven-day course of a progestogen is required each month for endometrial protection but can reproduce premenstrual syndrome-type symptoms in these women.To determine the effectiveness and safety (...) of articles retrieved.We included published and unpublished randomized placebo or active controlled trials on the efficacy of the use of non-contraceptive oestrogen-containing preparations in the management of premenstrual syndrome in women of reproductive age with PMS diagnosed by at least two prospective cycles without current psychiatric disorder.Two review authors independently selected studies, assessed risk of bias, extracted data on premenstrual symptoms and adverse effects and entered data

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2017 Cochrane

16. Adolescents and Long-Acting Reversible Contraception: Implants and Intrauterine Devices

About Contraception, for more information (20). Obstetrician–gynecologists should engage adoles- cents who wish to prevent pregnancy in shared decision- making and provide information on the benefits and risks of all contraceptive methods. Contraceptive counseling should include anticipatory guidance for adolescents and their parents or guardians regarding possible menstrual changes, side effects, and noncontraceptive benefits such Counseling, Consent, Confidentiality, and Cost Adolescent (...) be removed (and replaced if the patient desires). Ideal management of low-lying IUDs is less clear; a shared decision-making approach between the patient and the obstetrician–gynecologist or other gynecologic care provider based on symptoms and other considerations is most appropriate. For additional information, see Committee Opinion No. 672, Clinical Challenges of Long-Acting Reversible Contraceptive Methods (43). Contraceptive Implants The Contraceptive Implant Has Minimal or No Effect on Bone Density

2018 American College of Obstetricians and Gynecologists

17. Hormonal Contraceptives

with both) Contraindications and side-effects similar to combined oral contraceptives Transdermal patch (Evra): Releases estradiol 35mcg and norelgestromin 200mcg per day Change patch once weekly for 3 weeks, followed by one week off. May use consecutively, without a hormone-free interval, for 9-12 weeks Initiate on 1st day of menses, or 1st Sunday after menses begins. 7 days of backup method recommended Possibly higher spotting rate and breast symptoms compared to oral contraceptives If weight > 90 kg (...) with the same product, refer the patient to her doctor or contact her doctor with a recommendation for a product less likely to cause the side effect See if patient has missed any pills and knows what to do if she does Reassess possible drug interactions or any new risk factors Table 1: Oral contraceptives for pharmacist prescribing Brand Names Components (EE = Ethinyl estradiol) Progestin only Micronor® Norethindrone 0.35mg 1 st Generation LoLo™ (24/2/2 regimen) 24 pills of: EE 10mcg Norethindrone 1mg 2

2018 medSask

18. Emergency Contraception

Not recommended for use more than once during same menstrual cycle Theoretical interaction with hormonal contraceptives: preferably avoid in women who have used hormonal contraception in the past 7 days. Do not initiate or resume hormonal contraception for at least 5 days after taking ulipristal; abstinence or barrier method of contraception is required for 14 days following ulipristal dose C) Yuzpe Method Older method, not widely used any more Less effective (37%), higher incidence of side effects due (...) to estrogen component Two doses (q 12 hours) of various combined oral contraceptives (See Table 1 below) Similar concerns as with levonorgestrel EC in regards to reduced effectiveness in overweight women Table 1: Yuzpe method dosing Product Tabs / dose Ethinyl estradiol / levonorgestrel mcg/dose Alesse®, Alysena™, Esme, Lutera™ 5 100/500 Triquilar® 4 yellow 120/500 Min-Ovral®, Portia®, Ovima™ 4 120/500 3) EC Drug Interactions: Hormonal contraception (HC) Levonorgestrel: HC can be started the day

2018 medSask

19. A Study to Assess the Effectiveness and Side Effects of GSK2798745 in Participants With Chronic Cough

A Study to Assess the Effectiveness and Side Effects of GSK2798745 in Participants With Chronic Cough A Study to Assess the Effectiveness and Side Effects of GSK2798745 in Participants With Chronic Cough - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please (...) remove one or more studies before adding more. A Study to Assess the Effectiveness and Side Effects of GSK2798745 in Participants With Chronic Cough The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT03372603 Recruitment Status : Terminated (Study terminated due to lack of efficacy of GSK2798745

2017 Clinical Trials

20. Selected practice recommendations for contraceptive use

- common side-effects - health risks and benefits - signs and symptoms that would necessitate a return to the clinic - return to fertility after discontinuation - STI protection. Information should be presented using language and formats that can be easily understood and accessed by the client. • Women who frequently experience user errors and women who anticipate experiencing user errors with user- dependent methods (e.g. oral contraceptive pills, the combined contraceptive transdermal patch (...) evidence warrants. Medical eligibility criteria for contraceptive use Guidance on who can use contraceptive methods safely Selected practice recommendations for contraceptive use Guidance on how to use contraceptive methods safely and effectively Family planning: a global handbook for providers Decision-making tool for family planning clients and providers Target audience: Providers of contraceptive counselling and services Target audience: Policy makers and programme managers 7administered

2017 World Health Organisation Guidelines

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