Elagolix Reduces Heavy Menstrual Bleeding in Women with Uterine Fibroids

Women with uterine fibroids who used elagolix with add-back therapy saw a reduction in heavy menstrual bleeding.

Abnormal bleeding is 1 of the most common indications of uterine fibroids and hysterectomy in the US, lead investigator William Schlaff, MD, a reproductive endocrinology and infertility physician at Jefferson University, told in an interview. The oral dose of elagolix with hormonal add-back therapy had a better effect than injectable medications.

Schlaff and colleagues from academic medical institutions across the US conducted 2 identical, double-blind, randomized, placebo-controlled, six-month phase 3 trials—Elaris uterine fibroids 1 (UF-1) and 2 (UF-2). The investigators evaluated the safety and efficacy of elagolix at a dose of 300 mg 2 times a day with hormonal add-back therapy in women with bleeding due to fibroids.

In roughly 70% of women, elagolix reduced abnormal bleeding, Schlaff said.

UF-1 and UF-2 each consisted of a 2.5–3.5 month screening period, a six-month treatment period, and a twelve-month follow-up period. The investigators randomly assigned the women to either receive a 300 mg dose of elagolix with add-back therapy twice a day, a 300 mg dose of elagolix alone twice daily, or placebo in a matched, double-blind, double-dummy manner.

The primary end point of the research was menstrual blood loss < 80 ml during the final month and at least a 50% reduction in menstrual blood loss form baseline to the last month. Some secondary end points included the change in menstrual blood loss from baseline to the end, the percentage of women who had suppression of bleeding at the end of the study, and the change from baseline in blood loss at 6 months.

Eligible women were premenopausal, between 18–51 years old at the time of screening, and had ultrasonography-confirmed uterine fibroids and heavy menstrual bleeding diagnoses.

Women reported their symptoms over the previous 4 weeks on the Uterine Fibroid Symptom and Quality of Life questionnaire. The questionnaire included a symptom severity score (0–100; higher scores indicated increased severity) and a health-related quality-of-life total score, which was the sum of scores on 6 subscales—concern, activities, energy and mood, control, self-consciousness, and sexual function. The scores ranged from 0–100, with higher scores associated with a better quality of life.

Source: HCP LIVE NETWORK

Reproductive endocrinology and infertility

Reproductive endocrinology and infertility (REI) is a surgical subspecialty of obstetrics and gynecology that trains physicians in reproductive medicine addressing hormonal functioning as it pertains to reproduction as well as the issue of infertility. While most REI specialists primarily focus on the treatment of infertility, reproductive endocrinologists are trained to also evaluate and treat hormonal dysfunctions in females and males outside infertility. Reproductive endocrinologists have specialty training in obstetrics and gynecology (ob-gyn) before they undergo sub-specialty training (fellowship) in REI.

Reproductivesurgery is a related specialty, where a physician in ob-gyn or urology further specializes to operate on anatomical disorders that affect  fertility.

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Gynecology Drugs Market Boosting The Growth | Leading Key Players Forecast 2018 – 2026

Transparency Market Research (TMR) has published a new report titled, “Gynecology Drugs Market – Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2018–2026”. According to the report, the global gynecology drugs market was valued at US$ 53.376.96 Mn in 2017. It is projected to expand at a CAGR of 5.5% during forecast period. The global gynecology drugs market is anticipated to be driven by rising incidence and prevalence rate of gynecological diseases during the forecast period. The gynecology drugs market in Asia Pacific is expected to expand at a high CAGR of 6.3%, due to the high prevalence of diseases, improvements in the health care sector, and increasing focus of key players on business expansion.

Worldwide increase in the prevalence of gynecological disorders

Gynecologic disorders affect the female reproductive system. The most common symptoms of gynecologic disorders include pelvic pain, vaginal itching, vaginal discharge, abnormal vaginal bleeding, and breast pain and lumps. The significance and severity of these symptoms often depend on age, as these symptoms may be related to hormonal changes that occur with aging.

Among other prominent gynecological diseases, sexually transmitted disease (STD) is the most common and critical – the most common STD among women is pelvic inflammatory disease. In the U.S. alone, more than one million women suffer from this disorder in their lifetime, followed by chlamydia – a sexually transmitted infection of the vagina, which, if left untreated, develops into pelvic inflammatory disease. Gynecological disorders may or may not be related to the menstrual cycle, which prominently include menstrual cramps and endometriosis (abnormally located patches of tissue that is normally located only in the lining of the uterus). Additionally, gynecological cancers are also common among women around the globe. Endometrial cancer and ovarian cancer are highly common among women. Therefore, increase in the prevalence of the conditions mentioned above, are likely to increase the uptake of gynecology drugs.

Rise in number of women facing menopausal conditions

Rise in number of women facing menopausal condition is a major factor that is expected to drive the market during the forecast period. Menopause is defined as permanent cessation of menstruation, resulting from loss of activity of ovarian follicles. In a majority of women, menopause is a natural event occurring at the age of around 51.3 years. The number of women entering menopausal condition is increasing year on year, due to unhealthy lifestyle and different environmental factors. In Canada, presently, over five million women aged between 45 and 65 have either gone through menopause or are expected to soon go through menopause. The average age of menopause in Canada is 51 years. Moreover, according to the Society of Obstetricians & Gynecologists of Canada, around 80% women claim to suffer from at least one menopausal symptom including mood swings, irritability, interrupted sleep, hot flashes, and vaginal dryness. Incidence of menopausal vasomotor symptoms has risen significantly in the last few years, which in turn drives the global gynecology drugs market.

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Cervical Cancer Awareness Month

Cervicalcancer is a cancer arising from the cervix. It is due to the abnormal growth of cells that have the ability to invade or spread to other parts of the body. Early on, typically no symptoms are seen. Later symptoms may include abnormal vaginal bleeding, pelvic pain or pain during sexual intercourse. While bleeding after sex may not be serious, it may also indicate the presence of cervical cancer.

Humanpapillomavirus infection (HPV) causes more than 90% of cases most people who have had HPV infections, however, do not develop cervical cancer. Other risk factors include smoking, a weak immune system, birth control pills, starting sex at a young age, and having many sexual partners, but these are less important. Cervical cancer typically develops from precancerous changes over 10 to 20 years. About 90% of cervical cancer cases are squamous cell carcinomas, 10% are adenocarcinoma, and a small number are other types. Diagnosis is typically by cervical screening followed by a biopsy. Medical imaging is then done to determine whether or not the cancer has spread.

HPV vaccines protect against two to seven high-risk strains of this family of viruses and may prevent up to 90% of cervical cancers. As a risk of cancer still exists, guidelines recommend continuing regular Pap tests. Other methods of prevention include having few or no sexual partners and the use of condoms. Cervical cancer screening using the Pap test or acetic acid can identify precancerous changes, which when treated, can prevent the development of cancer. Treatment may consist of some combination of surgery, chemotherapy, and radiation therapy. Five-year survival rates in the United States are 68%. Outcomes, however, depend very much on how early the cancer is detected.

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ABSTRACT SUBMISSION

GLOBAL EXPERTS MEETING ON FRONTIERS IN GYNECOLOGY AND OBSTETRICS  

At San Francisco, USA

During April 27-29, 2020

First round abstract submission closes on January 12th 2020.

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'Abortion Reversal' Treatments Are So Dangerous, a Study on Them Had to Be Stopped

Several states now require women who seek medication abortions to be provided with dubious information that the procedure could be stopped, allowing a pregnancy to continue.

But when researchers attempted to carry out a legitimate study of whether these "abortion reversal" treatments were effective and safe, they had to stop almost immediately - because some of the women who participated in the study experienced dangerous hemorrhaging that sent them to the hospital.

By passing these abortion reversal laws, "states are encouraging women to participate in an unmonitored experiment," Creinin said.

Creinin and his colleagues detailed their concerns in a commentary in the journal Contraception, and they will publish their study in January's edition of Obstetrics and Gynecology.

Medication abortions, which are used up to 10 weeks into a pregnancy, consist of taking two pills in sequence. The first pill in the regimen, mifepristone, loosens the pregnancy's attachment to the uterus. The second pill, misoprostol, forces the uterus to contract to push out the pregnancy. The pills must be taken consecutively to complete the abortion, and there's a chance the pregnancy will continue if the second pill is not taken.

A total of 862,320 abortions were provided in clinical settings in 2017, according to the Guttmacher Institute, about 39 percent of which were medication abortions. Research has shown that using these drugs is a safe way to end a pregnancy.

Some antiabortion activists and legislators claim that not taking the second pill, or giving a woman high doses of the hormone progesterone after taking mifepristone, can help stop, or "reverse," a medical abortion.

The American College of Obstetricians and Gynecologists firmly states that "claims regarding abortion 'reversal' treatment are not based on science and do not meet clinical standards" and say the purported studies that underpin these antiabortion arguments lack scientific rigor and ethics.

Despite this, the claims made in these discredited studies have worked their way to antiabortion lawmakers, who in turn have put them into abortion reversal legislation that was signed by governors in North Dakota, Idaho, Utah, South Dakota, Kentucky, Nebraska, Oklahoma and Arkansas. The laws are currently blocked or enjoined in Oklahoma and North Dakota.

Because reliable research on these treatments is nonexistent, earlier this year, Creinin and his colleagues designed a legitimate double-blind, placebo-controlled, randomized trial that aimed to observe 40 volunteers who had already elected to have a surgical abortion.

Their goal was to see if giving progesterone to women who took the first pill in the prescribed regimen would effectively and safely halt an abortion.

After the women took the first pill in the abortion protocol, mifepristone, rather than take the second pill, misoprostol, they were either given a placebo or a dose of progesterone.

Researchers only enrolled 12 women before they had to stop the study.

Bleeding is normal during a medication abortion. But three of the women who enrolled in the UC-Davis study experienced far more serious bleeding than anyone could have anticipated when the second pill was not administered.

One woman "was so scared she called an ambulance," while another woman startled by the amount of blood "called 911 and crawled into her bathtub", Creinin said. A third woman who went to the emergency room needed a transfusion. One of the women had received a placebo, while two others had taken the progesterone.

Creinin and his colleagues halted the study as soon as it became clear that they could not proceed safely.

"I feel really horrible that I couldn't finish the study. I feel really horrible that the women … had to go through all this," Creinin said. Because the study ended prematurely, the researchers could not establish any evidence that progesterone was an effective way to stop a medication abortion.

"What the results do show, though, is that there's a very significant safety signal" when it comes to disrupting the approved medication abortion protocol, Creinin said.

Source: Science alerts

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When ovarian cysts become a cause for concern

At some point in their lives, most women do develop ovarian cysts — small, fluid-filled sacs that typically form during ovulation, and are located in or on the ovary. 

More often than not, these cysts are harmless and painless, and will go away on their own without the need for treatment. However, it becomes a problem when it does not go away or grows bigger. 

While most ovarian cysts do not present any symptoms, it might be time to schedule a medical check-up if you experience bloating or swelling of the abdomen, constipation or pain during bowelmovements, irregular menstrual periods, as well as lower abdominal or pelvic pain before or during your menstrual cycle. 

Severe cases might be accompanied by nausea and vomiting. In such a scenario, your doctor may order an emergency pelvic ultrasound to rule out ovarian cancer. 

TYPES OF OVARIAN CYSTS

Dr Cindy Pang, obstetrician and gynae-oncologist from Mount Elizabeth Novena Hospital, says there are different types of cysts.

Functional cysts occur as part of the menstrual cycle. These can cause problems sometimes in women in the reproductive age group. In the first half of the cycle – the follicle – which contains the developing egg, can grow up to 2cm before ovulation. After ovulation, the corpus luteal cyst or the egg shell will persist till the start of the next menstrual cycle. If all is good, this process goes on monthly. However, some patients may have hormonal problems leading to the follicle increasing in size, or there could be bleeding into the corpus luteal cyst. This can lead to water cysts and blood cysts forming.

Benign pathological cysts due to processes not related to ovulation can also form. For example, dermoid cyst – which contains hair or sebum and other tissue – can develop from the cells on the ovaries. Another example is endometriotic cyst, which are blood filled cysts due to the lining of the uterus growing on the ovary. These can increase in size and grow independent of the menstrual cycle. 

And then there are cancerous cysts. The lifetime risk of a woman getting ovarian cancer is one in 74 — or about 1.3 per cent. It can affect women of any age, but those who are older, have had breast cancer previously or have a family history of ovarian cancer, may be at a higher risk of developing the disease. The ultrasound will usually show sinister features like solid areas in the cyst and increase blood supply. 

The symptoms of cysts can be vague. A slowly growing cyst can cause symptoms with bloating or swelling of the abdomen, constipation or pain during bowel movements. There could be irregular menstrual periods, as well as lower abdominal or pelvic pain before or during your menstrual cycle.

If the cyst is leaking or twisting at the blood supply, which is medically known as ovarian cyst torsion, the presentation can be sudden with severe lower abdominal pain with nausea and vomiting. This is called an ovarian cyst accident. Surgical intervention is usually needed on an emergency basis as delay can cause the ovary and its surrounding tissue will be damaged, which may affect fertility.

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