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  phase III combined oral contraceptive trials (1950s)

  experience with depot medroxy-progesterone acetate (Depo-Provera®; Upjohn) and norethisterone enanthate (Schering, 1960s)

  WHO evaluation and research program (1970s)

  Expert WHO/NIH/Population Council consultations (from 1979)

90 days reference period Definitions

Collabora've  Study  Group.  Eur  J  Contracept  Reprod  Health  Care  1998  

90 days reference period Definitions

.

.

Collabora've  Study  Group.  Eur  J  Contracept  Reprod  Health  Care  1998  

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Bleeding Patterns Shifted reference period 1

0 10 20 30 40 50 60 70 80

amenorrhoea 1-2 B/S episodes

3-5 B/S episodes

6 or more B/S episodes

prolonged

Desogestrel POP starters/switchers

30 µg LNG starters/switchers

%

Collabora've  Study  Group.  Eur  J  Contracept  Reprod  Health  Care  1998  

*

* **

Bleeding pattern Reference period 4

0 10 20 30 40 50 60 70 80

amenorrhoea 1-2 B/S episodes

3-5 B/S episodes

6 or more B/S episodes

prolonged

Desogestrel starters/switchers 30 µg LNG starters/switchers

%

Collabora've  Study  Group.  Eur  J  Contracept  Reprod  Health  Care  1998  

Collabora've  Study  Group.  Eur  J  Contracept  Reprod  Health  Care  1998  

Overview

0

30

60

90

120

# of

wom

en

RP1Overall

1 2 3 4 5 6 7 8

Reference Period

FrProl3-5ProlInProlFreq3-5InfreqAmeno

112 105 104 101 99 95 99 87

0

30

60

90

120

# of

wom

en

RP1Overall

1 2 3 4 5 6 7 8

Reference Period

FrProl3-5ProlInProlFreq3 5InfreqAmeno

114 99 91 85 71 77 72 62

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Breakthrough bleeding with progestogen-only sub-dermal implants

  breakthrough bleeding is common   usually unpredictable, infrequent, short and light   frequent and unpredictable episodes of breakthrough

bleeding occur in a significant minority of women using progestogen-only contraceptive implants

  occasionally these episodes may be prolonged, but rarely heavy

  amenorrhoea in 15 - 20%   these may lead to premature discontinuation   Patterns may change with time

Implanon - concerns about bleeding patterns in individual women

Menstrual patterns associated with premature discontinuation of LNG-implants

(Family Health International; 11 countries; 3419 women)

FIGO Menstrual Disorders Working Group

  Menstrual terminology confusion  FIGO recommended terminologies (2007)  FIGO Classification of underlying causes of

abnormal uterine bleeding (AUB) (2011)   PALM-COEIN   based on idnetification of “structural” and “non-

structural” causes   progestogen-related bleeding is non-structural

(no lesions imaged) and iatrogenic

Bleeding, culture and contraception

 Views vary on menstruation and acceptability of amenorrhoea   Between developing and

developed countries   Between different cultures,

religions, ethnicities

WHO Task Force, Stud Fam Plann, 1981; Glasier et al. Contraception 2003; Edelman et al. Contraception 2007

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Bleeding, culture and contraception

  In late 1970s most women preferred a monthly bleed –  It was an ‘outlet’ for bad

blood –  It was felt to be a ‘cleansing’

process –  It showed ‘good health’ –  Amenorrhoea was unnatural

and could ‘damage’ future fertility

–  It showed they were not pregnant

WHO Task Force, Stud Fam Plann, 1981; Glasier et al. Contraception 2003; Edelman et al. Contraception 2007

Acceptability of amenorrhoea associated with contraception

  In the 1970s 53% of British and 91% of Pakistani women  did not want amenorrhoea

  Now 72% of women from developed countries  accept amenorrhoea in a contraceptive

method and appreciate the benefits

Glasier et al. Contraception 2003; Edelman et al. Contraception 2007

Unacceptable vaginal bleeding patterns for women

 Unacceptable bleeding patterns as judged by women include   Prolonged bleeding   Frequent bleeding   (amenorrhoea)

Mansour  D    et  al.  Contracep'on.  2011;83:202-­‐10