Predictors of Abnormal Uterine Bleeding in Progestin-only Contraceptives Users

Abnormal Uterine Bleeding and Progestin-only Contraceptives



Sponsors

Lead Sponsor



Source

Assiut University

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief 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.

Overall Status

Recruiting

Start Date

2018-06-01

Completion Date

2019-02-01

Primary Completion Date

2019-01-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Number of women developed vaginal bleeding
6 months

Enrollment

300

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

Injection every 3 months

Arm Group Label

Group I "the depot medroxy-progesterone acetate group"


Intervention Type

Drug

Intervention Name


Description

68 mg implant

Arm Group Label

Group II "Implanon group"


Intervention Type

Drug

Intervention Name


Description

one pill every day for 35days without pill-free interval.

Arm Group Label

group III (Microlut group)



Eligibility

Criteria

Inclusion Criteria:

1. Women who will use the method only for pregnancy prevention for at least 6-12 month.

2. Have not any known or incidental gynecological ultrasound abnormalities.

3. Have not any medical or gynecologic problem.

4. Living in a nearby area to make follow-up reasonably possible.

Exclusion Criteria:

- Refuse the participation in the study.

Gender

Female

Minimum Age

20 Years

Maximum Age

40 Years

Healthy Volunteers

No


Location

Facility

Status

Contact

Women Health Hospital - Assiut university
Assiut 71111 Egypt
Recruiting
Last Name: Mohammed K ALi, MD
Phone: +201005537951
Email: m_khairy2001@yahoo.com

Location Countries

Country

Egypt


Verification Date

2018-04-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Assiut University

Investigator Full Name

Mohammed Khairy Ali

Investigator Title

Lecturer


Has Expanded Access

No

Condition Browse


Number Of Arms

3

Intervention Browse

Mesh Term

Contraceptive Agents

Levonorgestrel

Etonogestrel

Medroxyprogesterone

Medroxyprogesterone Acetate

Progesterone

Progestins



Arm Group

Arm Group Label

Group I "the depot medroxy-progesterone acetate group"

Arm Group Type

Other

Description

where they will use Depot Medroxyprogesterone Acetate 150 mg injection every 3 month,


Arm Group Label

Group II "Implanon group"

Arm Group Type

Other

Description

where they will have Implanon (etonogestrel implant) 68 mg implant


Arm Group Label

group III (Microlut group)

Arm Group Type

Other

Description

where they are using Microlut pills (0.5 mg levonorgestrel) one pill every day for 35 days without pill-free interval.



Firstreceived Results Date

N/A

Patient Data

Sharing Ipd

Undecided


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Non-Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Prevention

Masking

None (Open Label)


Study First Submitted

January 7, 2018

Study First Submitted Qc

January 7, 2018

Study First Posted

January 12, 2018

Last Update Submitted

April 21, 2018

Last Update Submitted Qc

April 21, 2018

Last Update Posted

April 24, 2018


ClinicalTrials.gov processed this data on September 21, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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