Abnormal Uterine Bleeding and Progestin-only Contraceptives

Contraception Clinical Trial

Official title:

Predictors of Abnormal Uterine Bleeding in Progestin-only Contraceptives Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03398811
• Other study ID #: POCU
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: November 1, 2020

Study information

• Verified date: December 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: November 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contraception
• Uterine Hemorrhage

Intervention

Drug:
• Depot medroxy-progesterone acetate
Injection every 3 months
• Etonogestrel
68 mg implant
• Desogestrel 75 µg
one pill every day for 28 days without pill-free interval.

Locations

Country	Name	City	State
Egypt	Women Health Hospital - Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of women developed vaginal bleeding		12 month