Natazia/Qlaira approved by the FDA

Qlaira; estradiol valerate/dienogest tablets to be sold in the U.S as Natazia

U.S. FDA Approves Natazia(TM), a New Oral Contraceptive for the Prevention of Pregnancy
05.07.10, 08:06 AM EDT
PRNewswire

“WAYNE, N.J., May 7 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Natazia (TM) (estradiol valerate and estradiol valerate/dienogest) tablets for the prevention of pregnancy. Natazia has not been evaluated in women with a BMI of greater than 30 kg/m(2) [the equivalent of a 5’7” woman weighing 190 lbs]. Natazia is the first and only oral contraceptive that contains an estrogen called estradiol valerate and a progestin called dienogest. Estradiol valerate is a synthetic estrogen that is converted to estradiol in a woman's body. Natazia is expected to be available in the summer.

Until today, all marketed combination oral contraceptives (COCs) contained ethinyl estradiol. With the FDA approval of Natazia, Bayer HealthCare Pharmaceuticals becomes the first company [in the U.S.] to launch estradiol valerate together with the progestin, dienogest.

"Every woman's body reacts differently to hormones, so it is important that they have a choice in birth control options," said Anita Nelson, MD, professor of obstetrics and gynecology at the Harbor-UCLA Medical Center, Torrance, California. "Natazia may be a good option for women to consider when making a decision with their healthcare provider about which birth control option is right for them."

Women using COCs, including Natazia, should be strongly advised not to smoke. Smoking increases the risk of serious cardiovascular side effects from COC use. The risk increases with age and the number of cigarettes, especially in women over 35 years old.

Natazia is taken once a day. The dosing regimen consists of pills with varying doses of estradiol valerate, and estradiol valerate in combination with dienogest, for specific days of the 28-day cycle.” The text in brackets [ ] was added by me for clarification.

Personal comment: I think Natazia should be available from U.S. pharmacies some time in the 3rd quarter of this year. It comes at a good time for Bayer because Yasmin/Yaz is under pressure from lawsuits claiming injury from side effects caused by the progestin drospirenone. Qlaira became available in Europe in May of 2009. Women interested in the patient information leaflet for Natazia are (for now) being referred to the Qlaira PIL at Qlaira.

Readers questions & the butcher shop

The Mirena levonorgestrel releasing IUD

Recent questions from readers:

Mirena IUD: “Taking out a Mirena drops estrogen or progestin?” A Mirena continuously releases a tiny bit of the progestin levonorgestrel. So removing it will decrease the average level of progestin in a woman’s body. I hope the reader asking this question was a man. A woman should have known the answer. Well, perhaps she was a very young woman who had abstinence-only sex-ed classes.

An IUD that has perforated the uterus

The problem with an IUD that has a frame, the T-shaped plastic structure to which the vertical copper coil or progestin releasing polymer is attached, such as a ParaGard (that uses copper) or Mirena is that it can dislodge or perforate the uterus and migrate into the wearer’s abdominal cavity - as in the image above - where it is ineffective as birth control.

Pregnant Escorts: “Escort fucks her client bareback to get pregnant” I’m not entirely sure what the reader is asking here. Most of our escorts have GyneFix IUDs implanted so to a client she would appear to be unprotected as do the girls on hormonal contraceptives. We do that to provide the most natural experience possible. Though of course we will use any standard contraceptive method a client would like. If the reader is a man he could be concerned about the complications from a paternity suit or perhaps he is secretly fantasizing about impregnating a favorite escort. In reality, up-market working girls want to stay as far away as possible from becoming preggers by a client. Pregnancy means expense and time off w/o pay to take care of the problem.

However, we do have a premium ‘baby-dancing’ service where the escort is fertile and totally unprotected with the object that the man pushes his shaft deep into her vagina slippery with fertile cervical fluid and buried as deep as he can get pumps semen into his escort’s ripe cervix soft, open and waiting to accept his sperm. The client has to commit to financing the abortion or the cost of carrying the baby to term and the adoption process if he actually manages to impregnate her. That service is extremely expensive and as far as I know no man has been successful in getting his baby-dancing escort preggers.

Prince Albert Piercing: “Can my Prince Albert piercing block my sperm preventing me getting my wife pregnant.” That’s the sort of question a stallion should ask his urologist. However, our clinic’s experience with men who wear PAPs during unprotected sex is that they are virile and potent if the piercing has been done correctly so that the man is able to urinate a strong stream. There may be some leakage around the piercing site below the frenulum, but if the man has strong ejaculations that place his semen deep in his partner’s vagina he should be capable of easily impregnating an unprotected partner. There is a question about damage to sperm if the PAP is of copper. No one knows for certain but it’s thought that if copper is used copper ions might react like they do from a copper IUD in the uterus and harm the wearer’s sperm.

Dive-Gel intimate lubricant: “Does Dive-Gel help with anxiety?” Dive-gel is an intimate lubricant that is difficult to wash away with water so is ideal for use as a lubricant during penetrative sex underwater. It will not reduce anxiety unless the person is anxious about being properly lubed for sexual intercourse underwater.

Qlaira missed pills: I keep getting questions about missed pills while on the birth control pill Qlaira. These questions are usually from women in Europe because Qlaira isn’t available in the U.S. yet. The instructions for taking missed pills while on Qlaira are complicated so the best thing for a woman to do is to consult the patient information leaflet that comes with each pill-pack. An on-line copy is available here. The only thing that is straightforward is if you miss one of the two white (inactive) pills just throw it away. Also, if you need to use back-up the interval is nine continuous days.

Sex at 30 meters: A good friend and frequent reader asked: “What kind of difference have you felt between doing what you do at the bottom of the Pit and going at 100 feet/30 meters?”

It's not that much different except for the amount and type of gas needed and the length of decompression. The interesting thing is the comments of my friends who are all freaked by the fact that they are at the mid point of the well and there is another 100 feet of water below them if something goes wrong. Of course that’s why we all carry lift bags as back-up. If there is an equipment failure or the diver is sick the idea is to get to the surface and if something goes wrong with the weight dump and the buoyancy device a lift bag can get you to the surface, but there isn't much control and it's tricky - and often impossible - to stop for deco ascending on a lift bag.

The butcher shop; Lean teen: Beth went with me on her first cleanup w/o Taryn. The victim was an 18 y/o aspiring dancer and from what was left seemed to have had a lean hard body. They found her in the studio of a ballet school run by a rubber Domme where she trained in the evenings. She was new in town and interested in rubber encasement and was slaughtered in her latex catsuit. To me it looked as though she was butchered by someone newly into Gynophagia. Nearly all the time Gynophagia is only an extreme fantasy fetish. But on rare occasions there have been reports of women actually being roasted and eaten. Anya says Deiter was deep into Gynophagia and ate parts of several Bosnian ballet dancers in his fortress castle in Germany. Deiter was a nasty piece of work and I’m thinking that Adolph may have some of the same tendencies.

The reason I say her butcher may have been newly into Gynophagia is that the cuts where he severed her thighs from the hips sockets were jagged as were the cuts that severed the lower parts of her legs just above the knees. The killer appears to have used a scalpel to slit her rubber suit and for cutting through flesh and muscle and a cleaver to hack through the bone. Blood was splattered everywhere. Or perhaps he was just new at dissecting a living woman and excited because he didn’t open an artery and let her bleed out before he started cutting out the parts he wanted. We found her strapless FemCap in her mouth blocking her airway. The bruise on her neck indicated her killer cut off the blood to her brain by pressing on her carotid and then when she fainted stuffed her FemCap down her throat. Anya said that Dieter told her a deboned woman’s thigh roasted with crushed rosemary tastes just like pork loin from a suckling pig. From looking at her ribs and breasts there won’t be much fat on her thighs so I’m not sure she will cook up well if the thighs are to be basted in their own juices. I thought for sure he would have gutted her to take her liver and kidneys to boil for stock but the organs in her abdomen were untouched, she was just missing her thighs. I really hope this guy is passing through and doesn’t make a habit of hunting in Vegas.

I was pleased that Beth did so well. Of course the victim was fresh so there was just the scent of blood so no deterioration and the accompanying stench had started. She pitched right in and helped load the upper body and lower legs, the feet sill in Bloch pointe shoes, into the bodybag. The shoes were Beth’s size and style and since she has started pointe again I said she could have them as a souvenir since they were stock and didn’t have the victim’s name on them. They were Beth’s first ‘trophy’ which she intends to wear to class.

A strict disciplinarian

Leashed to the bottom and out of air

Abi’s incident rate: In the exclusive German girls academy where among other things she taught submerged bondage there was such a large number of near drownings or suffocations in her classes that even at a school noted for its strict discipline her methods were thought extreme. Abi is proud of being a strict disciplinarian and will tell you that strict discipline is quickest way to foster mental toughness and separate the sheep from the goats, but the final straw for the academy’s head mistress was a student’s suicide. Abi was asked to resign as the result of the suicide of a girl who had been sent back to Abi’s class after she was intentionally let run out of air as a breath control exercise while held underwater by an ankle leash. It wasn’t that she was forgotten. Abi just watched as the girl struggled trying to suck air out of an empty tank and fortunately just as she removed her reg the student stopped breathing. Drowning was never an issue, but the student didn’t know that. She was in only 10 feet of water in a one piece neoprene swimsuit so when Abi put her reg back in her mouth, turned on the air from the second tank in her training twin-set and hit purge on the student’s reg while holding it in her mouth filling her lungs she regained consciousness and when Abi released her ankle leash she immediately floated to the surface where she climbed out of the pool by herself, but was so terrified that she couldn’t speak. After weeks of recovery her parents insisted she finish school with an unblemished record so they forced her to return to Abi’s next class and her parents claim that her fear of Abi and the humiliation of being sent to train in a group of girls with less seniority was apparently more than she could stand and she jumped from a bridge on campus.

Qlaira and pregnancy: I think her suicide may have had as much or more to do with the fact that she was 10 weeks pregnant (they didn’t test for divers for pregnancy at that school) and her parents were very strict about her proper use of contraceptives. She was on Qlaira (estradiol valerate, and dienogest) and the effectiveness of her hormonal protection may have been compromised by the antidepressant meds she was on.

Blame: It seems to me that if anyone is to blame for her suicide it is the student’s parents for forcing her back into a situation she hated. Abi won’t go easy on a student just because she can’t take the discipline. Nor should she, as that would ruin her reputation as being strict but fair, something she is not willing to do. Teaching at Splash Abi will have more latitude with her training philosophy of pushing the envelope, which is that rather than ask permission it is better to ask for forgiveness later. That is especially true because Adolph is expecting some dropouts from her classes with whom he can ‘commune’ as he calls it. She said he hasn’t given her a quota but I’m sure he has a number in mind. Probably enough to keep his training facility occupied when he isn’t training Rubber-Femmes for their Doms.

NuvaRing, a reader’s question: A reader asked: Can you pull out a NuvaRing with a crochet needle? Yes you can, but there should be few instances where that sort of a removal aid is necessary when using NuvaRing. The ring usually positions itself by gravity low and against the back of the pubic bone where it can easily be hooked by a finger and pulled out at removal time. And, since the ring can be left in place for the 4th week and still be effective there is plenty of time to move your period so there should be no OMG! I’ve-got-to-get-it-out-now moment, unless you are hiding the fact that you are using it from your partner. If that’s the case there is a three hour max ring-out interval after which leaving it out longer decreases the hormone protection the ring provides and to be safe you need to insert and use another effective method of contraception for a minimum of 7 days while your hormonal protection is reestablished. There may be a few instances where the user wants to remove the ring immediately after intercourse where her partner has pushed it further toward the back of her vagina. If that’s the case then a crochet hook with a 10 mm hook can be used as a removal aid.

Missing pills on Qlaira

Qlaira: estradiol valerate and dienogest

The Qlaira twins: Sixteen y/o Austrian twins entered St Lucy’s for the Spring semester in January. They are on the new Beyer combined hormonal contraceptive pill Qlaira which is a combination of the estrogen estradiol valerate and the progestin dienogest. Since Qlaira isn’t available in the U.S. yet they brought a six month supply of the pills with them. Qlaira is a 4 level 28 day regimen pill which is simple to take. However, if a woman misses a pill or two she may not be able to get back on schedule w/o having a nine-day lapse in her hormonal protection. That is typical for a multi-phasic pill but as you can see from the instructions below if a pill (or pills) is missed it depends on where the woman is in her pill pack as to what she should do to protect herself while she gets back on schedule. From the patient instructions that come with the pills:

“What do I do if I miss a pill?

The Qlaira packet contains 26 colored active tablets and 2 white inactive tablets. These must be taken in the order specified on the pack.

You should try and take your pill at the same time every day to help you remember to take it.

If you forget to take one of the white inactive pills this doesn't matter. You will still be protected, just discard the missed inactive pill and continue to take your pills, one every day, as normal.

If you forget to take an active pill, you should take it as soon as you remember (even if that means taking two pills in one day) and then continue to take your pills, one every day, as normal. Don’t take more than two active pills in one day. If you miss more than one pill you should ask your doctor for advice.

If you are less than 12 hours late taking an active pill you will still be protected against pregnancy and don’t need to use any extra precautions.

If you are more than 12 hours late taking an active pill, you may not be protected against pregnancy. What to do next depends on where in the packet you missed the pill.

If you have forgotten to start a new packet of pills, or have forgotten to take a pill on day 1 to 9 of the packet, you should use extra contraception such as condoms for the next nine days, while continuing with normal pill taking. If you had unprotected sex within the previous seven days there is a possibility you could be pregnant and you should seek medical advice.

If you miss a pill on days 10 to 17 of the packet, then it is necessary to use extra contraception, such as condoms, for the next nine days, while continuing with normal pill taking.

If you miss a pill from days 18 to 24 of the packet, don’t take the missed pill, discard the current packet and start a new packet started immediately. You will need to use extra contraception such as condoms for the next nine days.

If you miss a pill on day 25 to 26 of the packet, then the missed pill should be taken immediately and then the next pill at the usual time. In this case, no extra contraception is necessary.

If you miss a pill on days 27 or 28 this doesn't matter as these pills are inactive. You will still be protected, just discard the missed inactive pill and continue to take your pills, one every day, as normal.

If you are confused about any of this, you can get individual advice for your circumstances from your doctor, pharmacist, local family planning clinic, or by calling the fpa helpline on 0845 122 8690.”

Missed pills complications: In my opinion this sort of corrective pill regimen is way too complicated to expect 16 y/o girls to follow it with any degree of accuracy. It’s not that they aren’t smart enough to follow the steps; it’s that they think they don’t need to and that they will be fine. Even though I cover the need to follow their pill regimen exactly it in my contemporary sexual health classes it’s hard to get some of them to believe they are at risk when they don’t take their pills correctly. So, I had mixed feelings when I heard that both twins were newly preggers. They found out when they went to SCUBA fundamentals class and the first test they took was for pregnancy and they tested positive for hCG.

The bad news is that they will miss a week of SCUBA lessons while they take care of their situations with Mifeprex. The good news is that they are at the age of consent so we don’t need to rely on their parental wavers in case someone questions their terminations. But the best thing from my perspective is that their situation gives me a teaching moment. The twins make a high profile object lesson in how not to take birth control pills, because they had both missed 2 pills and didn’t use a back-up method. They had been fitted for starter gas guards (Semina diaphragms) but chose not to use them or condoms for the nine days that their pill instructions called for while their hormonal protection was being reestablished.

Rebreather bag tampering: A frequent cause of serious accidents in the rubber fetish community is from misuse or tampering with rebreather bags. We are seeing an increase in asphyxia injuries and deaths and the most common equipment arrangement in these accidents is a 3 liter black latex rebreather bag with an adaptor screwed into the canister port of a surplus gasmask with a flip valve on the other end. I have seen everything from gluing the valve closed to pushing a wood or plastic rod into the valve opening to block it. Or the wearer is under the influence of recreational drugs or alcohol and passes out before he can open the rebreather valve.

If you are wearing a vintage gasmask with an exposed canister connector – the sort of rig that’s called a ‘starter set’ here because it is inexpensive and favored by men new to breath play - another simple way to create a rebreather is with a latex male condom. Condoms work well if the user oxygenates first before stretching the open end across the 40 mm NATO canister connection. The problem with that arrangement is there is no valve so the partner using a condom on his mask (rebreather bags are almost exclusively used by men here) needs to have at least one hand free and be mentally alert enough so he can remove the condom or his partner needs to be watching so that s/he can remove it before the wearer suffocates.

Cervical rams: We had a sadistic rubber Dom who was using a rubber lined polymer penis sheath as a ram to cripple women, even ones with extremely deep vaginas. It sounds like something Adolph might do but it wasn’t him. It is almost as though the Dom was wearing a strap-on as it had the same effect on a woman often rupturing her uterus as she squirmed and screamed beneath him trying to get away. He seemed to use it on the older Subs in his stable so he could say they had health issues and cut them loose to work the streets. That came to an end last weekend while he was watching the Colts and Saints game and drinking double shots of Chivas Regal. When he passed out several of his girls fitted his gasmask over his face tightened the head harness straps to get a good seal and screwed a rebreather on to his mask, then closed the valve and let him suffocate. They were packed and ready to leave splitting the cash he kept in a safe in his bedroom as getaway money. His housekeeper found him Monday morning. I don’t know of a single person who will mourn his death.

Gepetto’s BDSM ballet-boots: To meet the needs of the BDSM community here Gepetto has modified his basic ballet-boot design. There is no padding in the toe-box so the wearer’s toes need to be taped and toe-pads used, or not, depending on her Doms requirements. Added to this design were shaft top locks and D-rings welded into the titanium heel cups so that they can’t be pried or cut off with bolt cutters. The D-rings can easily take the wearer’s weight hanging from her boots or can be locked to a spreader bar. Each pair comes with a complementary titanium vaginal hook and six-foot chain leash so that with her crotch zipper open a rubber Dom can lead his Sub in her heavy rubber encasement suit through the crowds at Naughty Pleasures w/o her getting away from him. When a girl is being lead around on a leash terminating in a vaginal hook you can believe she is seriously intent on keeping slack in the leash.