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An ounce of Prevention

Jayata Sharma explores the market for current and under-research contraceptive methods and devices.

As strange as it may sound, the idea of contraception actually stemmed in the 18th Century. When camels, the only means of transport in deserts, used to get pregnant, its owners devised a way of preventing pregnancy. They discovered that inserting a small stone in the uterus, would prevent conception. We have, of course, come a long way since then.

Divide and Rule

Contraceptives can be of two types—permanent and temporary. Permanent consists of sterilisation and vasectomy, while the temporary method can be further divided in to behavioral methods, barrier methods, hormonal and emergency contraceptives.

Behavioral methods

These methods were the earliest ones to be practised. The withdrawal method is wherein a male when approaching ejaculation, pulls out of the vagina. The main risk of 'coitus interruptus' is that the man may not make the maneuver in time.

In rhythm method, one calculates the ovulation period and avoids intercourse on those days. Yet another method was to have unprotected intercourse only during the lactational ammonorrhea period of the women. However, this method can be used only when the woman is exclusively breast feeding and only up to six months, else the failure rate raises furthermore. And the last behavioral method is abstinence. After the discovery of better contraceptives, these methods have taken a backseat.

Barrier methods

"Most women prefer injections, as they do not have to worry about taking a pill every day" - Dr Rekha Daver, Gynaecologist JJ Hospital, Mumbai

As the name suggests, barrier methods work on the principle of creating a barrier.

Male condoms: The oldest, and according to gynaecologists, the best method of contraception is the male condom. Although doctors say it also protects against sexually transmitted diseases (STDs), men perceived it as an obstruction. Doctors advise couples to use condoms with other contraceptive methods like spermicides.

Spermicides and Diaphragm: Spermicides, which kills sperms, can be in form of vaginal pills, contraceptive sponge, contraceptive creams and contraceptive gels.

The diaphragm fits behind the woman's pubic bone and has a firm but flexible ring, which helps it press against the vaginal walls. The diaphragm covers the cervix, the entrance of the uterus, and block sperms from entering the female reproductive tract.

According to experts, spermicidal jelly and creams used in a diaphragm retains its full spermicidal activity for 12 hours after placement of the diaphragm.

Diaphragms are normally available in the size of 70mm. "However, the diaphragm has been replaced by newer methods like the cervical cap and female condoms," says Dr Hara Pattanaik, an Orissa-based gynaecologist.

Female condoms: The female condom was introduced to enable women to protect against infections and unwanted pregnancies. They were launched in India last year, and cost around Rs 100 per condom. This method is the only alternative contraceptive method to prevent STDs apart from male condoms. They were made available by the Indian Government free of cost to the commercial sex workers for the feasibility study. “However, it is not popular and didn't work well, as the female condom is costly and cumbersome,” informs Dr Rekha Daver, Professor and Head, Gynaecology Department, JJ Hospital, Mumbai.

Made of thin polyurethane, it is a sheath with two soft, flexible rings at either end and is worn internally by the woman during sex. The polyurethane covers one ring, which sits up against the cervix and acts as an anchor for the condom. The second ring is larger and remains outside the body. It covers part of the perineum and labia during intercourse. The female condom can be inserted as much as eight hours prior to intercourse, but it should be removed immediately after. It should also not be used with a male condom. On the positive side, though, since the female condom is made of polyurethane and not latex, it can safely be used with oil-based lubricants.

Lea's Shield, not available in India, was introduced in 2002. Made of medical grade silicone, it is a cup-shaped device that is inserted into the vagina in order to prevent sperm from entering the cervix. Designed to be reusable, it is completely washable and lasts for a period of about six months.

Hormonal methods

Hormonal methods work by providing two hormones, viz, estrogen and progesterone in the body. The hormones can be taken in the form of oral pills, injections, IUDs, contraceptive patches, and implants. However, women over 35 years of age, obese women, pregnant and lactating women are not advised hormonal methods. In some cases, there is also a danger of cervical cancer or breast cancer.

Oral pills: They were introduced in the 1960's. However, due to numerous myths, like it leading to cancer and irregular periods, shrouding it, oral pills were sidelined. "Now, the younger generation is much more open to oral contraceptives. They are comfortable with the fact that their menstruation cycle will not be regular," says Dr Sonia Malik, a Delhi-based infertility expert and also a member of the Menopause Society of India.

Pills are available for 28 days and 21 days and are of two types: the combination pill (containing estrogen and progesterone), and progestin-only pill (POP), also known as the mini-pill.

The combination birth control pill is made up of synthetic estrogen and progesterone. The main function of this type of oral contraceptive is to suppress ovulation. This is done through the increased levels of estrogen the body receives from the pill. However, today's birth control pills contain far lesser amounts of estrogen than their predecessors. As a result, ovulation may still occur anywhere from 2 to 10 per cent of the time. Although preventing ovulation is the primary method through which the pills attempt to prevent pregnancy, the extra estrogen and progesterone also work to thicken the cervical mucus. This makes it more difficult for sperm to reach an egg. Ovarol L, Nuleton, Femilon, and Novelon are some of the combination pills available in the Indian market. A special type of combination pill called as the sequential pill, in the brand name of Triquilar, is available in India. This pill mimics the human system of producing hormones and at first only estrogen pills are taken and then progesterone ones.

Mini-Pill contains only progesterone and is advised for women who are pregnant, lactating, are smokers, and regularly consume alcohol. Estrogen is avoided in the above group of females as it is a strong hormone and hence can cause serious complications.

"Copper T is popular as it is a one-time procedure which is long-term and the patient follow-ups are least" - Dr Jaideep Malhotra, Gynaecologist and FOGSI Member, Agra

Intrauterine devices (IUDs): Introduced in 1952, Copper T, (Copper T 220 and Copper T380) is a preferred method. "This method is popular as it is a one-time procedure which is long-term and the patient follow-ups are least," says Dr Jaideep Malhotra, Gynaecologist and FOGSI Member, based in Agra.

Copper T, which uses both hormones, is inserted in the uterus and has a copper wire wound around the device, which releases 35 microgram of hormones inside the body everyday.

Injectable contraceptives: Contraceptive injections are available as monthly hormone injections, bi-monthly injections, and quarterly injections. Injections work by suppressing ovulation and may also thicken the cervical mucus to create a hostile environment for sperms, and also thin the uterine lining to make implantation of a fertilised egg difficult. "Most women prefer injections, as they do not have to worry about taking a pill every day," says Dr Daver.

However, the flip side is high dose to be given in one shot. One of the most common side effects is the change in the menstruation cycle during the first year of use, which affects a quarter to half of all users. Also, there can be an increase in bleeding, weight gain, change in libido, and increase or decrease in facial and body hair. Usually, these side effects wear off within a few weeks.

Implants: They use only progesterone. The earlier implant (brand name Norplant) was first introduced in 1990 and was worn for up to five years. However, women had the option of removing it after a minimum three years. Norplant was made up of six tiny silicone rods that contain progestin. These rods were implanted under the sub-dermal tissue of the upper arm. Norplant is no longer used as the removal of the implant is more costly, more time consuming and can cause scarring. Also, about half of all users choose not to wait for five years to remove their implants before the three year mark. Norplant was recalled from the market in 2002, and newer single rod implants in the brand names of Norplant 2 and Implanon were made available internationally in 2006. These work to thicken the cervical mucus, thereby creating a barrier for sperm. They also suppress the ovulation as well as thin the lining of uterus, which would hinder the implantation of a fertilised egg.

Norplant 2 and Implanon come prefilled with progesterone and are attached to a syringe. So, instead of a minor surgical procedure, it can be given as a shot.

Although implants are effective, they are still not available commercially in India. But, a ray of hope is that research by a team of gynaecologists on single-rod implant has been done in India at 15 Human Reproduction Research Centres (HRRCs). "We have handed over the report to ICMR and it will take upto four years more for implants to come in the Indian market," says Dr Daver, who is the Principal Investigator with ICMR, NACO and WHO. The implant procedure can be done in the hospital/clinic and takes about 10 minutes.

Contraceptive Patch: A contraceptive patch, which is a transdermal adhesive, is also available, but only internationally. The patch uses estrogen and progesterone to suppress ovulation, thickens the cervical mucus and possibly thins the uterine lining too. However, instead of taking these hormones orally, this contraceptive allows the hormones to be continuously delivered directly into the bloodstream via a thin patch.

The patch is available under the name Ortho Evra and is replaced every week. The patches are placed on the buttocks, abdomen, upper torso (excluding the breasts) or the upper outer arm for three consecutive weeks. The patch is worn at all times, even while exercising, bathing or in hot, humid conditions. On the fourth week, the patch is removed and users will most likely receive their period during this week. "Patches are not ideal for Indian climate. There is so much humidity that the patch comes out," says Dr Duru Shah, Mumbai-based Gynaecologist, with special interest in infertility. The birth control patch is currently used by more than five million American women.

Pros and cons of the alternatives

Pills: + Help with acne problems. + Easing of PMS symptoms. + Protection against ovarian cancer as well as endometrial cancer. - Spotting. - Breast tenderness. - Decrease in libido and weight gain. - No protection against sexually transmitted diseases (STDs).

Injected: + No need to take daily. + Long-term results. - Change in menstruation (may be lighter or heavier; shorter or longer). - Increase in spotting and breakthrough bleeding. - Weight gain. - Dizziness.

Female condom: + Protection against STDs. + Use of polyurethane instead of latex, makes it safe to be used with oil-based lubricants. - Cumbersome to use. - More expensive than a male condom.

Implant: + Continuous protection against pregnancy for as much as five years. + Breastfeeding women can safely use implant. - Menstrual disturbances and irregularities. - Headaches/migraines. - Weight gain.

Copper T: + Continuous protection up to 10 years. + Provided by Government free of cost. - Heavy bleeding. - Takes long time for effects to reverse after removal.

Emergency methods

Emergency contraceptive pills, also known as 'morning-after pill' was made available in the market in 2000. They are to be taken within 24, 48 or 72 hours after having unprotected intercourse. Livologesterone is the active agent in emergency pills.

Doctors insist that users take them only when there is actually an emergency and when the other forms of contraceptions fail. "It is sad to see that young females are using emergency pills as a regular contraceptive method," says Dr Nozer Sheriar, a Mumbai-based Gynaecologist. Regular usage can harm the fertility of the female. Besides failing to protect against STDs, there is always a risk of prominent side-effects due to strong doses.

However, doctors think they have better option for such emergency situations now. "With the invention of livologesterone, doctors have a choice to offer. Also, this hormone is mild on the body and does not cause any side-effect," says Dr Sheriar.

Sterilisation

In sterilisation, the fallopian tube is cut, hence the female cannot get pregnant ever again. Vasectomy is a procedure wherein the males are operated and the production of sperms is ceased. The procedures do not take more than six hours and the person can walk back the same day. Now-a-days, couples are not keen on sterilisation and so doctors have found out another way for women. The procedure is still called the same but now it does not cut the tube but just blocks it by falap rings or falap clips. This occludes the tube enough to not get pregnant. However, if after some years, the couple feels the desire to have another child or because of the death of their child, they can remove the block and the female can again get pregnant. "I advice my rural patients to go in for sterilisation after raising their family. But for the urban women, I and even they, prefer reversible contraceptive methods," avers Dr Malik.

Under research

As people prefer reversible contraceptives over irreversible ones, research is conducted only on temporary contraceptives.

A vaginal contraceptive ring is under research, which alters the endometrium and hence prevents pregnancy. The lining of the uterus changes daily and vaginal ring will release hormones according to the lining at that time.

Implants are also in the human trial stage in India. Around 3,000 women have enrolled for the study of the single-rod contraceptive implant with the ICMR. “Recently, some women insisted on removing the implants, and their fertility returned in two-three months,” informs Dr Daver.

Dr Reddy's is currently involved in research on female condoms. Through ICMR, gynaecologists under the guidance of Dr Daver will soon start research on the comparison of the Indian made female condom and the foreign ones.

Also, researchers from the University of Utah have developed a vaginal 'molecular condom' that starts as a fluid substance to be inserted by a woman vaginally, and becomes a gel at body temperature and at the vaginal fluid pH of 4.2, and then in the presence of sperm with a pH of 7.7, it become a liquid again, only to release an antiviral drug load to block infection of HIV.

The University researchers claim that the gel is designed to release anti-HIV drugs when the gel comes into contact with semen during intercourse. Sadly, the molecular condom is five years away from tests in humans and roughly 10 years until it might be in widespread use.

Male contraceptive oral pills are also under research. These work by suppressing the sperm formation in a male. However, in the animal trials, it was discovered that oral pills in males lead to men losing potency. In addition, contraceptive injections for males are being researched, which will release contraceptive drug into the blood stream over a period of weeks to months. Male hormonal contraceptive is being researched, which would be a small implanted device placed under the skin. A method to interfere the maturation of sperm in the epididymis, which is the long, coiled tube through which sperms pass after exiting the testes, is being worked upon. It is believed that the drugs targeting this phase of sperm development would become effective faster.

In addition, a heat-based contraception, which involves heating the testicles to a high temperature for a short period of time to prevent formation of sperms, is being researched. While a study has found certain heating regimens to be effective and reversible, there is currently no interest in funding larger studies in the US and the UK.

Also under research in Phase II internationally is the usage of papaya seed extract. Compounds derived from papaya seeds and ingested by males immobilised and killed sperm in animal tests, and in human tests—with no toxicity, no side effects, and no decrease in testosterone. The effect is reversible. However, it takes around 90 days for the extract to actually give results.

jayata.sharma@expressindia.com