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Completed

NCT Number: NCT03398811

Abnormal Uterine Bleeding and Progestin-only Contraceptives

The use of progestin-only methods of contraception has been increased obviously and progressively over the world in the last few years. Progestin-only contraception is an option for women in whom an estrogen-containing contraceptive is either contraindicated or causes additional health concerns.

Progestogen-only pills are contraceptive pills that contain only synthetic progestogens (progestins) and do not contain estrogen . The progestin-only pill is recommended over regular birth control pills for women who are breastfeeding because the mini-pill does not affect milk production.

The most common progestin-only method used is the injectable depot medroxy-progesterone acetate which had been approved by Food and Drug Administration since 1992 . depot medroxy-progesterone acetate provides reliable, private, long-acting (three months) and reversible contraception. Users of depot medroxy-progesterone acetate don't need daily taking as well as it doesn't affect the intercourse by any mean.

The etonogestrel implant (Implanon) is a single-rod progestin contraceptive method placed subdermally in the inner aspect of upper non dependant arm for three years. Much evidence supports the safety, efficacy, reversibility and acceptability of this contraceptive method.

A common reason women choose to discontinue progestin-only contraception is dissatisfaction with its effects on uterine bleeding which occurs in a significant number of users. Information revealed from many clinical trials shows that abnormal uterine bleeding with progestin-only contraception ranging from 10 to 25 % at first year of use.

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Key information

Conditions

Contraception

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged between 18-40 years.
  • Women with more than 12 month postpartum.
  • Women who had normal menstrual pattern (cycle from 21 - 35 days with a same cycle length variation of no more than 5 days, bleeding days from 2-7 days and number of sanitary pads not more than 3 pads without blood clots or flooding of blood).
  • Women wanted to use DMPA, etonogestrel subdermal implant or POPs only for pregnancy prevention for at least 1 year.

Exclusion criteria

  • Women on any anticoagulant therapy.
  • Women who had a history of uterine, cervical or ovarian pathology.
  • Women who had uterine bleeding disturbance (including amenorrhea) before recruitment.
  • Women received DMPA injection within the previous 9 months except they had three spontaneous regular menstrual cycles.
  • Severely anemic women (hemoglobin < 8gm/dl).
  • Women with any contraindications for POCs following the WHO eligibility (Altshuler AL et al., 2015).
  • Women refused to participate in the study.

Treatment and study plan

Depot medroxy-progesterone acetate

Drug

Injection every 3 months

Etonogestrel

Drug

68 mg implant

Desogestrel 75 µg

Drug

one pill every day for 28 days without pill-free interval.

Primary outcomes

  1. Number of women developed vaginal bleeding

    Time frame: 12 month

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Predictors of Abnormal Uterine Bleeding in Progestin-only Contraceptives Users

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 12, 2018
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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