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Yahoo
a day ago
- Health
- Yahoo
Feeling Exhausted During Your Period? Here's Why—And What To Do, According To Doctors
Even if you're not relying on a trusty cycle tracker, everyone has their sure-fire signs that their period is about to begin. Maybe you get a breakout or start to feel more sensitive. Me? I start to feel fatigue. I'm not alone; 71 percent of women report feeling tired during their period, according to a study in the American Journal of Obstetrics and Gynecology—and that only makes up one part of fatigue. Feeling fatigue during your period actually isn't all that surprising if you think about it; your body is doing a lot of work. 'The energy required for menstruation—uterine contractions and shedding of the uterine lining—can contribute to fatigue,' says Kelly Culwell, MD, an ob-gyn and nationally renowned women's health expert. Plus, the very hormones that are changing in your body might cause increased exhaustion, as might those other symptoms you're feeling like cramping, headaches, or difficulty sleeping. Understanding the causes of your period fatigue and related symptoms can be helpful—especially if your low energy is interfering with your everyday life. And if your fatigue persists month after month, it could be worth a visit to your provider. Ahead, medical experts define the causes and symptoms of period fatigue, what to do about it, and when to see a doctor. Meet the experts: Kristin Markell, MD, is an ob-gyn based in Springdale, Arkansas. Kelly Culwell, MD, is an ob-gyn and former medical officer for the World Health Organization (WHO). Don't underestimate how tiring simply getting a period can be. All those symptoms you have to deal with month to month like cramps, headaches, or even just bleeding can all contribute to overall fatigue, says Dr. Culwell. What to do about it: Start by treating your period symptoms. That means using over-the-counter meds for pain management for cramps. Plus, although you may not feel super motivated to work out, staying active may actually help boost energy levels (and help you find relief) during your period, says Dr. Culwell. Regular exercise has been associated with a reduction in physical and psychological symptoms of PMS, per a review done by researchers at Ohio State University. 'Although it may sound counterintuitive, trying to get exercise and some time outside each day can help improve mood and sleep, both of which can help improve symptoms of fatigue,' she says. Fatigue during your period could also simply be due to the normal hormone changes that occur throughout a cycle, Dr. Culwell says. 'The drop in the hormones estrogen and progesterone just before menstruation can lead to decreased energy and depressed mood,' she says. So, for some people, fatigue is a period symptom. What to do about it: Do what you can to support your hormone health, including getting a good night's rest, eating a healthy, varied diet, and staying active—even though it can be hard to do so when you're getting your period. 'It's almost like a loop where you're less active and so you are actually more fatigued, but then you don't want to be more active because you're fatigued,' Dr. Culwell says. But you don't have to do a full 60-minute HIIT workout. Going for a leisurely walk should do the trick. If you notice that any efforts you may take aren't improving your fatigue, it may be time to seek additional support from a doctor who can advise on next steps. It's completely normal to have a light period on some days and a heavy one on others. That said, people who consistently have a heavy flow may experience low energy and fatigue more often, says Kristin Markell, MD, an ob-gyn. That's because heavy bleeding means losing more iron. Fatigue and iron deficiency are more common for women who experience heavy bleeding, per a study published in Haemophilia. Though it's not necessarily always a cause for concern, heavy bleeding might be a sign of something more serious, Dr. Markell says. If you notice common symptoms of anemia like lethargy, weakness, chest pain, changes in your skin complexion, trouble regulating your temperature, or an irregular heartbeat, you might want to speak with your doctor, Dr. Markell says. What to do about it: If low iron is behind your period fatigue, the first step is talking to your doctor, who can order blood work to get to the bottom of your levels. While some level of iron loss is normal during menstruation, if you are losing a lot of blood—and experiencing symptoms like fatigue—you should get it checked out. After that point, you might be recommended dietary tweaks, an iron supplement, or an iron infusion to get you back to a good place. 'Lack of sleep—either due to other menstrual symptoms or hormonal changes—can also cause fatigue,' says Dr. Culwell. And, you guessed it: your period can totally mess with your sleep. The menstrual cycle can cause changes in your circadian rhythm, interrupt your sleep cycle and even give you bad dreams, according to a study in Sleep Medicine Research. One reason why? Your basal body temperature changes at different points in your cycle, affecting how well you catch those Zzzs, per a study in Physiological Reports. What to do about it: Getting proper rest may seem like an obvious way to combat period fatigue, but quality sleep isn't always possible for everyone—especially if your fatigue is consistent and lasts days on end. Small habit changes can help, though, like taking a power nap during your lunch or pulling back on high-intensity workouts while on your period. You can also go to your doctor to talk about other options, like cognitive behavioral therapy or medications. There are a few more serious conditions that might result in increased fatigue during your period—but it wouldn't be the only symptom you experience, says Dr. Culwell. Endometriosis and fibroids are two conditions that can cause fatigue because they cause pain and heavy bleeding. It's also common for women to experience thyroid conditions, particularly hypothyroidism, which can impact fatigue too. What to do about it: If you experience heavy bleeding—as in, you go through a pad or tampon or pad in just an hour for multiple hours—go see your doctor. They can evaluate you for a number of conditions. When To See A Doctor Period fatigue isn't always a sign of something serious, but if your efforts to treat it with things like diet changes or pain management don't provide relief, it may be time to see a doctor. Consistently experiencing extreme exhaustion and very heavy bleeding may be signs of anemia, and both Dr. Markell and Dr. Culwell recommend that you see a doctor if you suspect this might be the case. 'If you have heavy menstrual bleeding or fatigue plus other symptoms like weakness, lightheadedness, headaches, or decreased exercise tolerance, you should see a healthcare provider to be evaluated for anemia,' Dr. Culwell says. The mental impact of period fatigue is worth noting, too. If you have extreme fatigue and worry you may have PMDD, tracking your symptoms can help since diagnosis requires a very specific set to be present, says Dr. Markell. Symptoms may include increased sensitivity to rejection, feeling tense or on edge, diminished interest in your usual activities, feeling overwhelmed or out of control, and sleeping too much (or not enough), among others. If you're concerned and noticing several of these symptoms, make an appointment with your doc for an evaluation. 'If fatigue symptoms are consistently affecting your quality of life and significantly changing your day to day activities, a visit with your healthcare provider is a good idea,' Dr. Markell says. You Might Also Like Jennifer Garner Swears By This Retinol Eye Cream These New Kicks Will Help You Smash Your Cross-Training Goals
Yahoo
25-02-2025
- Health
- Yahoo
FDA Approves MIUDELLA®, the First Hormone-Free Copper Intrauterine System (IUS) in the U.S. in Over 40 Years, from Sebela Women's Health Inc.
ROSWELL, Ga., Feb. 25, 2025 /PRNewswire/ -- Sebela Women's Health Inc., a part of Sebela Pharmaceuticals, today announced that the U.S. Food and Drug Administration (FDA) granted approval of MIUDELLA® (copper intrauterine system) for the prevention of pregnancy in females of reproductive potential for up to three years. MIUDELLA is a next-generation, hormone-free, low-dose copper intrauterine device or IUD, the first to be approved by the FDA in the United States in over 40 years. "Sebela Women's Health is thrilled to be able to bring this hormone-free IUD option for birth control to women in the United States," said Kelly Culwell, MD, Head of Research and Development, Sebela Women's Health. "Our innovative copper IUD MIUDELLA® offers effective pregnancy prevention using less than half the copper of the currently available copper-based IUD in the U.S., utilizing a small, flexible nitinol frame. We believe these and other features of MIUDELLA may help address barriers to use, while also providing women with the hormone-free option some prefer." Guidelines from the American College of Obstetrics and Gynecology state that long-acting reversible contraceptive (LARC) methods, including intrauterine devices and contraceptive implants, are the most effective contraceptive methods, have few contraindications, and are appropriate for almost all patients.1 While there are a variety of contraceptive methods available to women, 41.6 percent of pregnancies in the U.S. are unintended.2 MIUDELLA® is a hormone-free IUD with a flexible frame made of nitinol, a material that has super-elastic properties that enables strategic placement of the copper in a manner that allows the device to achieve similar efficacy to the currently available copper IUD with less than half the dose of copper (175mm2). MIUDELLA® uses the smallest hormone-free flexible IUD frame available in the United States, measuring 32 mm horizontally and 30 mm vertically with pre-cut retrieval strings. Miudella does not require loading by a healthcare professional; it comes fully preloaded within a tapered, rounded tip inserter with a small insertion tube diameter of 3.7 mm.3 "Considering it has been four decades since we've been able to offer women a new hormone-free IUD option, I find the clinical data supporting MIUDELLA® efficacy and safety to be very exciting," said Principal Investigator David K. Turok, MD, MPH, Professor, Department of Obstetrics and Gynecology, University of Utah. "This innovative intrauterine device may allow for improvements in discontinuation rates due to pain and bleeding and in expulsion rates. This would be very meaningful for women looking for hormone-free options." About MIUDELLA® MIUDELLA was investigated in three clinical trials in the U.S. in 1,904 women aged 17 to 45 years. The Phase 3 prospective, multicenter single-arm open-label study was conducted in 42 centers in the U.S. with a primary endpoint of contraceptive efficacy through 3 years of use as assessed by the Pearl Index (defined as the number of pregnancies per 100 women over one year). In the efficacy cohort from the Phase 3 study (n=1397), the first-year Pearl Index was 0.94 (95% CI, 0.43-1.78) and the cumulative 3-year Pearl Index was 1.05 (95% CI, 0.66-1.60) or 99% efficacy. Both clinicians and study participants also reported positive experiences with placement of Miudella, with an overall placement success rate of 98.8%. The most common adverse events across all three clinical trials were similar to those seen with use of IUDs – heavy menstrual bleeding, dysmenorrhea and intermenstrual bleeding. The incidence of these adverse events decreased over time. In the first year, 8.5% of participants across all three studies discontinued due to bleeding or pain adverse events, which decreased to 3.2% by year 3. Expulsion rates were low ranging from 1.9% in year 1 to 0.9% in year 3. MIUDELLA® will be available to patients through trained healthcare providers in the U.S. later in 2025. For more information on MIUDELLA, please visit IMPORTANT SAFETY INFORMATION Warning: Improper insertion of intrauterine systems, including MIUDELLA®, increases the risk of complications. Proper training prior to first use of MIUDELLA® can minimize the risk of improper insertion. MIUDELLA® is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MIUDELLA® REMS program to ensure all healthcare providers are trained on the proper insertion of MIUDELLA® prior to first use. Further information is available at and 1-855-337-0772. Contraindications: Don't use MIUDELLA® if you are or may be pregnant, have a uterine anomaly that distorts the uterine cavity and would be incompatible with correct IUS placement, acute pelvic inflammatory disease, postpartum endometritis or postabortal endometritis in past 3 months, known or suspected uterine or cervical malignancy, uterine bleeding of unknown etiology, untreated acute cervicitis or vaginitis or other lower genital tract infection, conditions associated with increased susceptibility to pelvic infections, Wilson's disease, a previously placed IUS that has not been removed and/or hypersensitivity to any component of Miudella including to polypropylene, copper, nitinol, an alloy of nickel and titanium, or any trace elements present in the copper components of Miudella®. Do not use MIUDELLA® for post-coital contraception (emergency contraception) Pregnancy with MIUDELLA® is rare but can be life threatening and cause infertility or loss of pregnancy. MIUDELLA® may attach to or go through the uterus and cause other problems. Tell your healthcare provider (HCP) if you develop severe pain or fever shortly after placement, miss a period, have abdominal pain, or if MIUDELLA® comes out. If it comes out, use backup birth control. At first, periods may be altered and result in heavier and longer bleeding with spotting in between. Tell your HCP you have MIUDELLA® before having an MRI or a medical procedure using heat therapy. Additional common side effects include painful periods, pelvic discomfort/pain, procedural pain, post procedural bleeding, and pain during sex. MIUDELLA® does not protect against HIV or STDs. Only you and your HCP can decide if MIUDELLA® is right for you. Available by prescription only. You are encouraged to report negative side effects of prescription drugs to the FDA at or call 1-800-FDA-1088. For important risk and use information about Miudella, please see Full Prescribing Information. About Sebela Pharmaceuticals® Sebela Pharmaceuticals is a US pharmaceutical company with a market leading position in gastroenterology and a focus on innovation in women's health. In addition to the newly approved MIUDELLA, Sebela Women's Health has another next-generation hormonal IUD for contraception in late-stage clinical development. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, is the market leader in colonoscopy screening preparations for over 35 years, having invented, developed and commercialized a broad portfolio of innovative prescription colonoscopy preparations and multiple gastroenterology products. Braintree also has several gastroenterology programs in late-stage clinical development including Tegoprazan which is in phase 3 trials for gastro-esophageal reflux disease (GERD), specifically, erosive esophagitis (EE) and non-erosive reflux disease (NERD). Sebela Pharmaceuticals has offices/operations in Roswell, GA; Braintree, MA; and Dublin, Ireland. Please visit for more information or call 844-732-3521. MIUDELLA is a registered trademark of Sebela Women's Health Inc. Forward Looking Statements This press release and any statements made for and during any presentation or meeting contain forward- looking statements related to Sebela Women's Health Inc. under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995, as amended, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the development, launch, introduction and commercial potential of IUDs as described herein; growth and opportunity, including peak sales and the potential demand for these IUDs, as well as their potential impact on applicable markets; market size; substantial competition; our ability to continue as a growing concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third-party payer reimbursement; dependence upon third parties supply and manufacturing uncertainties; our financial performance and results, including the risk that we are unable to manage our operating expenses or cash use for operations, or are unable to commercialize our products, within the guided ranges or otherwise as expected; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, are based on current expectations, and Sebela Women's Health Inc. does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances except as required by law. ContactSebela Women's HealthErinn Whiteerinn@ References ACOG, Clinical Practice Bulletin #186, Nov. 2017 reaffirmed 2021; Committee Statement #5, April 2023. Accessed on April 18, 2023: and Centers for Disease Control and Prevention. Accessed on Feb. 18, 2025. Creinin MD, Gawron LM, Roe AH, et al.; Copper 175mm2 IUD Phase 3 Clinical Investigator Group. Three-year efficacy, safety, and tolerability outcomes from a phase 3 study of a low-dose copper intrauterine device. Contraception. 2024 Nov 22:110771. doi: 10.1016/ View original content to download multimedia: SOURCE Sebela Pharmaceuticals Inc Sign in to access your portfolio
