Abnormal Uterine Bleeding and Progestin-only Contraceptives

Predictors of Abnormal Uterine Bleeding in Progestin-only Contraceptives Users

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: Depot medroxy-progesterone acetate; Drug: Etonogestrel; Drug: Desogestrel 75 µg

• Study Type: Observational
• Enrollment (Actual): 390

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Women Health Hospital - Assiut university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

women who requested DMPA, etonogestrel subdermal implant or POPs for pregnancy prevention.

Description

Inclusion Criteria:

1. Women aged between 18-40 years.
2. Women with more than 12 month postpartum.
3. 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).
4. Women wanted to use DMPA, etonogestrel subdermal implant or POPs only for pregnancy prevention for at least 1 year.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I "the depot medroxy-progesterone acetate group"; where they will use Depot Medroxyprogesterone Acetate 150 mg injection every 3 month,	Drug: Depot medroxy-progesterone acetate; Injection every 3 months
Group II "Implanon group"; where they will have Implanon (etonogestrel implant) 68 mg implant	Drug: Etonogestrel; 68 mg implant
group III (cerazette group); where they are using Cerazette pills (desogestrel 75 µg l) one pill every day for 28 days without pill-free interval.	Drug: Desogestrel 75 µg; one pill every day for 28 days without pill-free interval.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of women developed vaginal bleeding	12 month

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: January 7, 2018
• First Submitted That Met QC Criteria: January 7, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Uterine Hemorrhage; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Progestins; Contraceptive Agents, Male; Progesterone; Medroxyprogesterone Acetate; Medroxyprogesterone; Desogestrel; Etonogestrel
• Other Study ID Numbers: POCU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No