Combined oral contraceptive pills

1.  Chairperson Elect ICOG –Indian College of OB/GY
 National Corresponding Editor-Journal of OB/GY of India JOGI
 National Corresponding Secretary Association of Medical Women, India
 Founder Patron & President –ISOPARB Vidarbha Chapter 2019-21
 Chairperson-IMS Education Committee 2021-23
 President-Association of Medical Women, Nagpur AMWN 2021-24
 Nagpur Ratan Award @ hands of Union Minister Shri Nitinji Gadkari
 Received Bharat excellence Award for women’s health
 Received Mehroo Dara Hansotia Best Committee Award for her work as
Chairperson HIV/AIDS Committee, FOGSI 2007-2009
 Received appreciation letter from Maharashtra Government for her work in the
field of SAVE THE GIRL CHILD
 Senior Vice President FOGSI 2012
 President Menopause Society, Nagpur 2016-18
 President Nagpur OB/GY Society 2005-06
 Delivered 11 orations and 450 guest lectures
 Publications-Thirty National & Eleven International
 Sensitized 2 lakh boys and girls on adolescent health issues
Dr. Laxmi Shrikhande
MBBS; MD(OB/GY);
FICOG; FICMU; FICMCH
Medical Director-
Shrikhande Fertility Clinic
Nagpur, Maharashtra

2. COMBINED ORAL
CONTRACEPTIVES
DR.LAXMI SHRIKHANDE
SHRIKHANDE HOSPITAL
NAGPUR

3. Contraception is the
need of the hour
15.6 Million Abortions
Occur Annually in India
The Lancet Global Health—was conducted jointly by researchers at the International Institute for Population Sciences (IIPS), Mumbai; the
Population Council, New Delhi; and the New York–based Guttmacher Institute. 2017
World’s population expected to
reach 9 billion by 2050.
India accounts for 17% of
world’s population.

4. During the last 50 years, improvement of the
oral pill has been concentrated on
continuously
lowering the Estrogen dosage,
and developing newer generations of
Progestogens
to make “safer” and “made to order” pills
Gregory Pincus
The first research on the
Oral Contraceptive pill
50 Years

5. What are Combined Oral Contraceptives?
Monophasic Consistent dose in each active pill
Biphasic, triphasic Dosing of E/P varies through the cycle
Dose
High dose : >50μg Estrogen
Low-dose: 30-35 µg of estrogen (common),
Ultra low dose : 20 µg or less of estrogen
Pills per pack
21: all active pills
(7-day break between packs)
28: 21 active + 7 inactive pills
(no break between packs)
COCs are pills that contain low doses of 2 hormones, a progestin and an estrogen
Traits and types
Table adapted from Training Resource Package for Family Planning: https://www.fptraining.org/
Family Planning: A Global Handbook for Providers (3rd Edition, 2018)

6. Development of Hormonal Contraception
150 μg mestranol
50 μg EE
35 μg EE
30 μg EE
25 μg EE
20 μg EE
(10-15 μg EE)
lowering the Estrogen dosage Newer generations of Progestogens
Estrogen
component is
: Ethanyl
estradiol
Modifications to
neutralize the
androgenic
activity
Norethisterone
Levonorgestrel
Gestodene
Desogestrel
Drospirenone
Cyproterone acetate
Reducing
Androgenicity

7. Estrogens in newer COCs
Trying to reduce the dose of estrogen to the lowest possible without reducing efficacy
Study- 15μg EE + 60μg gestodene for 24/4 days: effective, safe, well tolerated, good cycle control
Barbosa, Contraception. 2006
Progestins in Newer COCs
Reducing the dose to the lowest possible without reducing efficacy (10 fold reduction)
Less androgenic
Negligible impact on carbohydrate and lipid metabolism
Potent inhibitors of ovulation - ↓ lower dose of estrogen needed
Can be used in treatment of acne and hirsutism

8. Commonly used Monophasic pills
Type Estrogen Progestin
Mala N EE 30 ug Norgestrel 300 ug
Mala D EE 30 ug Levonorgestrel 150 ug
Ovral L EE 30 ug Levonorgestrel 150 ug
Ovral G EE 50 ug Levonorgestrel 250 ug
Novelon EE 30 ug Desogestrel 150 ug
Femilon EE 20 ug Desogestrel 150 ug
Loette EE 20 ug Levonorgestrel 100 ug
Yasmin EE 30 ug Drospirenone 3 mg
Yaz EE 20 ug Drospirenone 3 mg

9. How do COCs work?
COCs work by
• Preventing ovulation: Suppress FSH, LH
• Preventing entry of sperms into uterine
cavity: By thickening of cervical mucous
• Preventing Implantation: By thinning the
endometrium
Preventing ovulation
Preventing
implantation
Preventing entry of sperms into
uterine cavity by thickening of
cervical mucous

10. How effective are COCs
When women take COCs on time and regularly as per recommendation:
Among 1000 women
using COCs over 1 year
3 may get
pregnant
Effectiveness depends
on taking each tablet
regularly and on time
Perfect use
99.7%
effectiveness
Effectiveness reduces to
92% if not taken as per
correctly and consistently
Typical use
92%
effectiveness

11. Who can use COCs
Safe for most women, including adolescents and women over 40 years old
After childbirth:
 not breastfeeding: after 3 weeks
 during breastfeeding: Can generally initiate COCs at 6 months postpartum
After abortion
Are living with HIV, whether or not on therapy

12. Prescribing COCs ….
CONSIDERATIONS
Co-morbidity
Screen and Assess medical
eligibility
CO-MORBITIES , CONTRA-INDICATIONS
Hypertension
Diabetes
Liver disease
Deep vein thrombosis
Migraine
Obesity
Cardiovascular disease
Breast cancer
Stroke
HIV

13. Screening prior to starting COCs
using the WHO MEC wheel
Category Recommendation

14. I am hypertensive and
I don’t want to get pregnant
Mild or controlled hypertension MEC 3 (generally do not use Combined hormonal
contraceptives -Risks outweigh benefits)
Hypertensive <35yrs, nonsmokers, no end-organ vascular
disease, no other cardiovascular risk factors with well
controlled HT – COC can be started under careful BP
monitoring
MEC 4 ( Do not use Combined hormonal
contraceptives)
Uncontrolled hypertension
with BP> 160/100
Combined Hormonal Contraceptives :
Studies have shown increase BP systolic by 8mm Hg and
diastolic by 6mm Hg with COC use

15. I am Diabetic and
I don’t want to get pregnant
COMBINED HORMONAL CONTRACEPTIVES
INCREASED RISK OF THROMBOSIS IN LONG STANDING DIABETES
Diabetes with nephropathy,
retinopathy, neuropathy or other
vascular disease and / or > 20
years
MEC 4 ( Do not use Combined hormonal
contraceptives)

16. Shulman LP. J Reprod Med. 2003.
Chang J. In: Surveillance Summaries. 2003.
Incidence
of
VTE
per
100,000
woman-years
0
20
40
60
High-dose
OC
Low-dose
OC
General
Population
Venous Thrombo embolism
COCs increase the risk of clotting
Additional factors – surgery, obesity, trauma and smoking
MEC 4 ( Do not use Combined hormonal
contraceptives)
Deep venous thrombosis (history or acute)
Pulmonary embolism (history or acute) :

17. Cardio vascular disease :
MEC 4 ( Do not use Combined hormonal
contraceptives)
Ischemic heart disease or stroke

18. WHO Category Conditions (selected examples)
Category 4 Breastfeeding: <6 weeks postpartum
Non-Breastfeeding: <3 weeks with risk factors for VTE
Smoking: ≥15 cigarettes/day and ≥ 35 yrs old
Vascular conditions:
• Hypertension (≥160/≥100)
• Migraines with aura
• Ischemic heart disease or stroke
• Diabetes with vascular complications
• Deep venous thrombosis (history or acute)
• Pulmonary embolism (history or acute)
Liver conditions:
• Acute hepatitis
• Severe liver disease and most liver tumors
Breast cancer: current or within 5 yrs
Who should not use COCs
Category 4 :
Adapted from Training Resource Package for Family Planning: https://www.fptraining.org/

19. Prescriptionof Oral Contraceptives
Medical history and physical examination
Confirm eligibility
Counseling
Begin COC at any time if reasonably certain is not pregnant
Start within 5 days of bleeding, continue taking one pill every
day
post abortion May be started immediately
Post partum :if breast feeding, to be started only after baby is
6 months,
Rapidly reversible, within 2-3 months conceptions are seen
Pelvic
exam not
needed
BP and
weight

20. When to start COCs
Normally
menstruating
woman
• Within 5 days of a
normal period
After delivery: (NVD
or LSCS)
• After 6 months in
breastfeeding
woman
• After 3 weeks if not
breastfeeding
After abortion:
(natural or
induced)
• Within 5 days of
the episode

21. What to do, if missed pills
Take one hormonal pill as soon as possible or two pills at scheduled time
Continue to take the rest of the pills each day at the regular time
If missed
1 pill
Take two pills immediately
Take another two tablets on the next day
Continue the others at the regular time
If missed
2 pills
If missed more than 2 pills, discard the missed pills, and continue
taking the rest of the pills at the regular time and use a condom
until next menstrual period. Meet the healthcare provider.

22. 5.1 %
National Family Health Survey – 5 (NFHS 5 ) 2019-21
Provider Bias towards COC

23. Our clinical Dilemma : Is contraception a risk ?
COC use – Cancer ? HT ? DM ? DVT ? Infertility ?
Pregnancy has a higher risk than
contraception, especially in high risk
medical conditions

24. Let’s Clear theconfusion !!!
Cancersand COCs
Carcinoma endometrium – COCs are protective !
◦ Use of COC for 12 months: 50% risk reduction
◦ Protection persists 20 yrs after discontinuation
Weiderpass E, cancer causes control.1999.
Epithelial ovarian cancers – COCs are protective !
◦ Even 3-6 months use: 40% risk reduction
◦ (3 yr use- notable impact, 10 yr use- 80% risk reduction)
◦ protection continues 20 yrs after stopping.
Royar J, Int J Cancer. 2001.
Carcinoma liver – no association !
WHO Colloborative study, Int J Cancer. 1989

25. Carcinoma cervix – no definite association !
– No significant increased risk of invasive carcinoma cervix
– Detection bias due to increased screening with pap smear
– I rwin KL, JAMA, 1988
Carcinoma breast – controversial, use caution !
• Known case of ca breast: COCs are C/I
Current use: ↑ early premenopausal ca breast, detection bias.
Past use: ↓ incidence metastatic postmenopausal ca breast
– ACOG Practice bulletin no 18, Obst & Gynecol. 2006
Cancers and COCs

26. Benefits of using COCs
Safe, easy to use
Regular periods
– less cramps,
moderate flow
Don’t interfere
with sex
Reduce risk of
ovarian and
endometrial cancers
Return of fertility
after COCs are
stopped:,
immediate
Completely
reversible
privacy to user Can be given by
healthcare workers

27. Rosenberg MJ, et al. Am J Obstet Gynecol. 1998;179:577-582.
Discontinuation of Oral Contraceptives
%
Discontinuing
0
2
4
6
8
10
12
Irregular
Bleeding
Nausea Weight
Gain
Mood
Changes
Breast
Tenderness
Headaches

28. Management of COC side effects:
Bleeding changes
Problem Action/Management
Irregular bleeding Reassure client: reinforce
correct pill taking and
review missed pill
instructions; ask about
other drugs that may
interact with COCs;
administer short course of
non-steroidal anti-
inflammatory drugs
If side effects persist
and are unacceptable to
client:
if possible, switch pill
formulations or offer
another method.
Amenorrhea Reassure client: no
medical treatment
necessary.
Adapted from Training Resource Package for Family Planning: https://www.fptraining.org/

29. Advise to stop taking COCs, use a backup method.
•Severe, constant pain in belly, chest, or legs
•Very bad headaches
•A bright spot in your vision before bad headaches
•Yellow skin or eyes
When to return: Warning signs of rare COC complications
Adapted from Training Resource Package for Family Planning: https://www.fptraining.org/

30. Other newer routes of administration of combined
hormonal contraception
Vaginal rings Contraceptive Patch Monthly combined Injectable

31. Nuvaring – vaginal ring
A flexible transparent ring of ethylene vinyl
acetate with an outer diameter of 54 mm and
cross-sectional diameter of 4 mm
One size for all!
Combined hormonal contraceptive vaginal
ring containing 2.7 mg ethinylestradiol and
11.7 mg etonorgestrel
It has the lowest oestrogen
content of any combined hormonal
contraceptive

32. Ingredients - Nuvaring
Every 24 hours the device releases:
15 mcg EE
120 mcg ENG
The hormones are absorbed into the
rich supply of blood vessels within the
vagina and enter the general
circulation, avoiding the first-pass
metabolism by the liver
Each Nuvaring is used for one monthly
cycle
It stay in the vagina for 3 weeks and is
then removed for a 1 week ring-free
interval
The 7 days without Nuvaring allows
for a withdrawal bleed
No daily pill taking; low dose; avoids 1st pass effect; low incidence of BTB or adverse effects; latex free

33. Evra - contraceptive patch
Daily dose 20mcg EE + 150 mcg Norelgestromin (similar
to Cilest)
Levels sufficient to inhibit ovulation for at least 7 days
Efficacy similar to triphasic COC (overall PI 1.24)
BTB more common in 1st 2 cycles than COC
Suitable for women with absorption problems, who are
forgetful or have difficulty swallowing pills

34. Combined injectable contraceptives (monthly
injectables)
Compared to progestin-only injectables DMPA monthly injectables:
Contain estrogen as well progestins, that is, combined methods.
Contain less progestin
More regular bleeding, fewer bleeding disturbances.
Require a monthly injection, whereas DMPA is injected every 3 months.

35. COCs: Summary
Safe for almost all women
Effective if used consistently and
correctly
Fertility returns without a delay
Screening and counseling are
essential
Adapted from Training Resource Package for Family Planning: https://www.fptraining.org/

36. Dr. Laxmi Shrikhande
Shrikhande Fertility Clinic
Ph-8805577600 / 8805677600
shrikhandedrlaxmi@gmail.com

38. The more you give, the more you will get.
Then life will become a sheer dance of love.
H. H. Sri. Sri. Ravishankar
The Art of Living
Thank you